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Cannabinopathic Medicine: Lester Grinspoon, M.D.’s New Coinage

Monday, April 29, 2013 @ 03:04 PM  posted by Teena Liberman

March 14th, 2013
Posted by Sunil Aggarwal

I am honored and delighted to be able to publish here for the first time a new comprehensive piece written by Dr. Lester Grinspoon, Emeritus Professor of Psychiatry at Harvard Medical School, entitled “Cannabinopathic Medicine”. Dr. Grinspoon started writing this piece in 2012, when I was privileged to read an early draft and give editorial suggestions. He has been looking for a suitable venue for publishing it where it could be read widely. I am grateful that he agreed to allow me to use this blog space to share it. It is approximately 6,000 words and well worth a read.

First, a brief introduction. Dr. Grinspoon, who is in his eighties, is a great physician and researcher who has been a co-author, instructive mentor, and guide of mine. He is known for his pioneering work on the social and medicinal uses of cannabis, but before that, he made significant contributions such as introducing the use of lithium in the treatment of bipolar disorder, the starting of the Harvard Mental Health letter, and many other achievements such as senior psychiatrist at the Massachusetts Mental Health Center in Boston for 40 years, fellow of the American Association for the Advancement of Science and the American Psychiatric Association, founding editor of the The American Psychiatric Association Annual Review, and editor of the Harvard Mental Health Letter for fifteen years, to name a few. It is a wonderful turn of events that Dr. Grinspoon’s home state Massachusetts passed a voter initiative by wide margin to legalize the medicinal use of cannabis for patients with conditions that a physician believes may benefit from its use. That law went into effect this year and now, as of this month, Harvard Medical School-affiliated faculty, in collaboration with the Massachusetts Medical Society, are producing and editing AMA-certified continuing medical education online course series on the medicinal uses of cannabis, vindicating Dr. Grinspoon’s remarkable foresight from over 40 years prior.

 

 

Without further adieu, here is Dr. Grinspoon’s latest piece on cannabis use, where we are going with it as a as society, and where we should be going.

Cannabinopathic Medicine byLester Grinspoon, M.D.

A native of Central Asia, cannabis (hemp) may have been cultivated as long as 10,000 years ago. It was certainly cultivated in China by 4000 BC and in Turkestan by 3000 BC. It has long been used as a medicine in India, China, the Middle East, Southeast Asia, South Africa, and South America. The first evidence of the medicinal use of cannabis is an herbal published during the reign of the Chinese emperor Chen Nung 5000 years ago. It was recommended for malaria, constipation, rheumatic pains, “absentmindedness”, and “female disorders.” Another Chinese herbalist recommended a mixture of hemp, resin, and wine as an analgesic during surgery. In India cannabis had been recommended to quicken the mind, lower fevers, induce sleep, cure dysentery, stimulate appetite, improve digestion, relieve headache, and cure venereal disease. In Africa it was used for dysentery, malaria, and other fevers. Today certain tribes treat snakebite with hemp or smoke it before childbirth. Hemp was also noted as a remedy by Galen and other physicians of the classical and Hellenistic eras, and it was highly valued in medieval Europe. The English clergyman Robert Burton, in his famous work The Anatomy of Melancholy, published in 1621, suggested the use of cannabis in the treatment of depression. The New English Dispensatory of 1764 recommended applying hemp roots to the skin for inflammation, a remedy that was already popular in Eastern Europe. The Edinburgh New Dispensary of 1794 included a long description of the effects of hemp and stated that the oil was useful in the treatment of coughs, venereal disease, and urinary incontinence.

However, in the West cannabis did not come into its own as a medicine until the mid-19th century. The first Western physician to take an interest in cannabis as medicine was W.B. O’ Shaughnessy, a young professor at the Medical College of Calcutta, who had observed its use in India. He gave cannabis to animals, satisfied himself that it was safe, and began to use it with patients suffering from rabies, rheumatism, epilepsy, and tetanus. In a report published in 1839, he wrote that he had found Cannabis Indica, (a solution of cannabis in alcohol, taken orally) to be an effective analgesic. He was also impressed with its muscle-relaxant properties and called it “an anticonvulsive remedy of the greatest value.”

O’Shaughnessy returned to England in 1842 and provided cannabis to pharmacists. Doctors in Europe and the United States soon began to prescribe it for a variety of physical conditions. Cannabis was even given to Queen Victoria for the treatment of her painful pre-menstrual cramps by her court physician. It was admitted to the United States Pharmacopeia in 1850 and commercial cannabis preparations soon became widely distributed through drugstores. Pharmacies welcomed the arrival of this “new” medicine, Cannabis Indica, because at that time their shelves held few truly effective drugs to offer the practitioners of allopathic medicine. As its use became increasingly widespread, clinical reports on cannabis accumulated and by the turn of the century, more than 100 papers were published in the Western medical literature recommending it for various illnesses and discomforts and extolling its remarkably limited toxicity.

The decline in the usage of Cannabis Indica began toward the end of the century. Both the potency of cannabis preparations and its absorption from the bowel were too variable, and individual responses to orally ingested cannabis seemed erratic and unpredictable. Another reason for the neglect of research on the analgesic properties of cannabis was the greatly increased use of opiates after the invention of the hypodermic syringe in the 1850s allowed soluble drugs to be injected for fast relief of pain; cannabis products are insoluble in water and so cannot easily be administered by injection. The end of the 19th century saw the development of such synthetic drugs as aspirin, chloral hydrate, and barbiturates. Two of the most common symptoms for which Cannabis Indica was prescribed were pain and insomnia, and now physicians could prescribe easy-to-take pills of known potency for these two problems, hastening the decline of cannabis as a medicine. But the new drugs had striking disadvantages. More than 1000 people die from aspirin-induced bleeding each year in the United States, and barbiturates are, of course, far more dangerous.

But the Marijuana Tax Act of 1937 was the ultimate death-knell for Cannabis Indica. This law was the culmination of a campaign organized by the Federal Bureau of Narcotics under Harry Anslinger in which the public was led to believe that cannabis, now commonly referred to as marijuana, was addictive and that its use led to violent crimes, psychosis, and mental deterioration; it is now confined to Schedule 1 under the Controlled Substances Act of 1970 as a drug that has a high potential for abuse, lacks accepted medical use, and is unsafe for use even under medical supervision. The film Reefer Madness, made as part of Anslinger’s campaign, may be a joke to the sophisticated today, but it was once regarded as a serious attempt to address a social problem; the atmosphere and attitudes it exemplified and promoted continue to influence our culture, albeit much less so today. The Marijuana Tax Act was not directly aimed at the medical use of cannabis; its purpose was to discourage recreational marijuana smoking. Almost incidentally the law made medical use of cannabis difficult because of the extensive paperwork and fees required of doctors who wanted to prescribe it. The Federal Bureau of Narcotics followed up with “anti-divergent” regulations that contributed to physicians’ disenchantment. Its removal from the United States Pharmacopeia and the National Formulary in 1942 signaled both the end of physicians’ interest in and allopathic medicine’s institutional embrace of cannabis. Furthermore, physicians allowed themselves to become ignorant about this drug as they have, since the mid-1930s, been increasingly exposed along with every other citizen to the deceptive propaganda against marijuana propagated by the United States government and such private organizations as the Partnership for a Drug Free America.

The concept of marijuana as a medicine virtually disappeared for several decades. Then in the 1960s, as large numbers of people began to use marijuana recreationally, claims of its medical utility began to appear, not in the medical literature but in the form of letters to popular magazines like Playboy. Typically these accounts were written by surprised and excited recreational users who had serendipitously discovered that marijuana relieved one or another of a variety of symptoms and syndromes. Over the next several decades, the grapevine word of these rediscovered medical utilities continued to grow. With the advent of the AIDS epidemic and the discovery of marijuana’s ability to reduce the nausea and therefore the threat of the “weight reduction syndrome of AIDS”, this reappearance of the concept of cannabis as a medicine gathered enough momentum to be publicly palpable. It was at this time that public pressure on the government to reconsider its obdurately held position developed in earnest, but with little success to date at the federal level.

There is an important difference in the way cannabis was used as a medicine in the latter
half of the 19th century and the way it has been generally administered since its reemergence as a sub rosa medicine in the mid-20th century. In its earlier iteration it was dispensed orally as an alcoholic solution; now it is primarily taken through the pulmonary system as smoke. The emergence of cannabis as a recreational drug began in the early part of the 20th century and has continued to grow. One of the reasons it has grown to the point where it can now be considered a part of Western culture is its introduction as a smokable drug. A good deal of mystery and uncertainty surrounds the story of the “reefer’s” debut in the United States. It is generally thought that in the early decades of the 20th century the custom of smoking “the weed” in cigarette form traveled with groups of itinerant Mexican workers across the border in the southern and southwestern states; it is now overwhelmingly the mode of administration used by the millions who use it as a medicine or for any other reason today.

This change in the route of administration has greatly enhanced its usefulness as a medicine because it solved the problem of providing the correct dose. One of the major problems that doctors in the 19th century faced with Cannabis Indica was that there were no reliable bioassays at that time and so physicians could never be sure that they had prescribed the correct dose. If too much was prescribed, the patient might experience discomfort in the form of anxiety but this would not be immediately evident because it takes about one to two hours for the effects of orally administered cannabis to be experienced. However, because physicians of the 19th century understood that this was a drug of unusually limited toxicity, they were not as concerned about overdosing as they were about providing an inadequate dose. The major advantage of smoking is the rapidity with which the medicinal effect appears; symptom relief will occur in a matter of minutes. And perhaps even more importantly, this very rapid feedback allows the patient to titrate his own dose for his particular symptom with much more precision than can his physician. He just leisurely puffs until one of two things happens; he either begins to experience symptom-relief or he becomes somewhat high or anxious at which point he stops. It is no longer believed that the smoke from marijuana is harmful to pulmonary or oropharyngeal tissues. But, for those patients who prefer not to smoke, there now is the option of using an instrument called a vaporizer which allows one to inhale the cannabinoids free of the combustion products of the cannabis plant.

In what may be the first attempt to reestablish the place of cannabis in mainstream allopathic medicine, the National Organization for the Reform of Marijuana Laws (NORML) in 1972 petitioned the Bureau of Narcotics and Dangerous Drugs, later renamed the Drug Enforcement Administration (DEA), to transfer marijuana to Schedule II so that the research necessary for the Food and Drug Administration (FDA) approval could be undertaken. Without this approval it cannot be clinically researched nor can it be legally prescribed. As the proceedings continued, other parties joined, including the Physicians Association for AIDS Care. It was only in 1986, after many years of legal maneuvering, that the DEA acceded to the demand for public hearings required by law. During the hearings, which lasted two years, many patients and physicians testified and thousands of pages of documentation were introduced. In 1988 the DEA’s own Administrative Law Judge, Francis L. Young, declared that marijuana in its natural form fulfilled the legal requirement of currently accepted medical use in treatment in the United States. He added that it was “one of the safest therapeutically active substances known to man.” His order that the marijuana plant be transferred to Schedule II was overruled, not by any medical authority, but by the DEA itself, which issued a final rejection of all pleas for reclassification in March 1992.

Meanwhile, growing demand forced the FDA to institute the Individual Treatment IND (commonly referred to as a Compassionate IND) for the use of physicians whose patients needed marijuana. The application process was made enormously complicated, and most physicians did not want to become involved, especially since many believed there was some stigma attached to prescribing marijuana. Between 1976 and 1988 the government reluctantly awarded about a half-dozen Compassionate INDs for the use of marijuana. In 1989 the FDA was deluged with new applications from people with AIDS, and the number granted rose to 34 within the year. In June 1991, the Public Health Service announced that the program would be suspended because it undercuts the Administration’s opposition to the use of illegal drugs. After that no new Compassionate IND’s were granted, and the program was discontinued in March 1992. Four patients are still receiving marijuana under the original program; for everyone else it is at the federal level an outlaw medicine.

Despite its federal illegality, beginning in 1996 with California’s passage of its Proposition 215, 18 states and the District of Columbia have established legislation which makes it possible for patients suffering from a variety of disorders to use the drug legally with a recommendation from a physician. Unfortunately, because each state arrogates to itself the right to define which symptoms and syndromes may be lawfully treated with cannabis, many patients with legitimate claims to the therapeutic usefulness of this plant must continue to use it illegally and therefore endure the extra layer of anxiety imposed by its illegality. California and Colorado are the two states in which the largest number of patients for whom it would be medically useful have the freedom to access it legally. New Jersey appears to be shaping up as one of the most restrictive, and for that reason it is likely that only a small fraction of the pool of patients who would find marijuana to be as or more useful than the invariably more toxic conventional drugs it will displace will be allowed legal access to it. The framers of the New Jersey legislation may fear what they see as chaos in the distribution of medical marijuana in California and Colorado, a fear born of their concern that the more liberal parameters of medical use adopted in these states have allowed its access to many people who use it for other than strictly medical reasons.

Because so many people are now having an opportunity to observe relatives or friends who are successfully, safely and relatively inexpensively using marijuana as a medicine, it will not be long before an overwhelming majority of citizens demand the same rights. There are now six other states working on medical marijuana legislation; this is a reflection of recent polls which show that more than 70% of American citizens now support the legal availability of marijuana as a medicine. These additional states and their citizens will inadvertently become part of an ongoing large social experiment in how best to deal with the reinvention of the “cannabis as medicine” phenomenon. Already we have learned a great deal from this ongoing experiment; one of the most important is that the states which have the more restricted and limited medical indications for allowable use of marijuana as a medicine have the largest number of patients who are compelled to use it illegally, while those which are the least restricted with respect to allowable medical indications unintentionally provide it to many people who use it for other purposes.

Shortly after O’ Shaughnessy introduced cannabis as a new medicine, modern Western medicine (allopathic medicine) signaled its acceptance when it was entered into the various Western pharmacopeia in the mid-19th century. It was expected, certainly by the 1990s, that it would be readmitted as a legitimate medicine, given the mountain of largely anecdotal evidence which establishes both its efficacy and safety, and its potential (once free of the prohibition tariff) to be much less expensive than pharmaceutical industry products it will replace. The two major agencies of this resistance to its readmission are the US government and the medical/pharmaceutical establishment.

Today drugs must undergo rigorous, expensive and time-consuming research to win approval by the FDA before they can be marketed as medicines. The first step made in trying to move the federal government was to petition it to move cannabis from its Schedule I status in the Controlled Substances Act to Schedule II so that it would then be possible to do the kinds of controlled studies essential to the presentation of any new drug to the Food and Drug Administration (FDA) for approval in accordance with the protocol used by the pharmaceutical industry. As noted above, the first attempt to petition the FDA and DEA to move marijuana to Schedule II was initiated in 1972 and after two decades of hearings and delays the DEA rejected all pleas for reclassification. Another two decades have passed and, with the exception of a handful of small-to-medium sized randomized controlled trials of smoked cannabis in chronic pain, spasticity, and wasting syndrome, the federal government continues to block the possibility of demonstrating that marijuana could satisfy the FDA criteria for a safe and efficacious addition to the pharmacopeia by continuing to insist, against overwhelming evidence to the contrary, that it is properly placed in Schedule I. In actuality it is now clear that marijuana no more belongs in Schedule I than does aspirin.

The purpose of the FDA testing is to protect the consumer by establishing both safety and efficacy. First, the drug’s safety (or rather, limited toxicity) is established through animal and then human experiments. Next, double-blind controlled studies are conducted to determine whether the drug has more than a placebo effect and is more useful than an available drug. As the difference between drug and placebo may be small, large numbers of patients are often needed in these studies for a statistically significant effect. Medical and governmental authorities insist that before marijuana is made legally available to patients, this kind of study should be performed for each of the indications for which it is proposed to be used. At the same time, the government refuses to reconsider its inappropriate assignment of marijuana to Schedule I, therein making it impossible by imposing a tight and heavily controlled monopoly on research-approved cannabis production and distribution to undertake the kind of studies presently demanded by the FDA for its reintegration into modern Western medicine.

But with the accumulation of an enormous amount of anecdotal evidence, it has now become doubtful whether these FDA rules should apply to marijuana. There is now little question about its safety. It has been used for thousands of years by millions of people with very little evidence of significant toxicity. Similarly, no further double-blind studies are needed to prove marijuana’s efficacy. Any astute clinician who has some knowledge of the accumulated clinical experience of patients who have used marijuana as a medicine knows that it is efficacious to some degree for many people with various symptoms and syndromes. Anecdotal evidence commands much less attention than it once did, yet it is the source of much of our knowledge of synthetic medicines as well as plant derivatives. Controlled experiments were not needed to recognize the therapeutic potential of chloral hydrate, barbiturates, aspirin, curare, insulin, or penicillin— pharmaceuticals introduced before the double-blind controlled study was invented.

Anecdotes present a problem that has always haunted medicine: the anecdotal fallacy or the fallacy of enumeration of favorable circumstances (counting the hits and ignoring the misses). If many people suffering from, say, muscle spasms caused by multiple sclerosis take marijuana and only a few get much better relief than they could get from conventional drugs, those few patients would stand out and come to our attention. They and their physicians would understandably be enthusiastic about marijuana and might proselytize for it. These people are not dishonest, but they are not dispassionate observers. Therefore, some may regard it as irresponsible to suggest on the basis of anecdotes that cannabis may help people with a variety of disorders. That might be a problem if cannabis were a dangerous drug but, in fact, it is remarkably safe. Even in the unlikely event that only a few people with multiple sclerosis find that it provides relief from muscle spasm, it can be argued that cannabis should be available to them because it costs so little to produce and the risks are so small.

The benefits of any medicine must be weighed against the risks. Fortunately, there is unusually good evidence on the potential health hazards of marijuana—far better than the evidence on most prescription drugs. Not only has cannabis been used for thousands of years by many millions of people, but there is much recent research on its safety inspired by the federal government’s interest in discovering toxic effects to justify its policy of prohibition. The potential dangers of marijuana when taken for pleasure and its possible usefulness as a medicine are historically and practically interrelated issues: historically, because the arguments used to justify the suppression of recreational use have had a disastrous influence on views of its medical potential; practically, because it is more likely to be safe as a medicine if it is relatively safe as a euphoriant. As the evidence makes it increasingly clear that cannabis is relatively benign, it is becoming more and more difficult to deny that a risk-benefit analysis now satisfies all requirements for medical use.

Penicillin was discovered in 1929, but the discovery was ignored by the medical establishment for more than a decade until the first clinical trial with six patients who suffered from a variety of infections; all were successfully treated. After this debut in 1941, penicillin rapidly earned the reputation as the wonder drug of the 1940s. It earned that reputation for three reasons: it was remarkably non-toxic, even at high doses; it could be produced inexpensively on a large scale; and it was extremely versatile, acting against microorganisms that cause a great variety of diseases, from pneumonia to syphilis. In all three respects cannabis suggests parallels: it is remarkably safe; once it is free of the prohibition tariff it will be inexpensive; and it is effective against a large number of symptoms and syndromes. Penicillin did not undergo modern FDA approval scrutiny because its safety and efficacy had been well established by the time the FDA adopted the present protocol for approving new drugs. Marijuana is now in the same position vis-à-vis the FDA; it has accumulated, both from recreational and medicinal use, more than enough evidence of its safety and efficacy.

As its reputation as a medicine grew, so did the demand for legal access. In 1996, California became the first state to provide legal (as far as the state was concerned) access for specified signs and symptoms and under controlled conditions. Over the next 15 years 16 other states and the District of Columbia followed suit, but the defined parameters of availability, particularly the rules for distribution and the medical reasons for which use would be allowed, have generally become more constricted. In these states the only involvement with the medical establishment is the requirement that the patient receive a note from a physician stating that he believes the patient’s condition would be helped by cannabis; these notes allow the patient to receive a state-issued medical marijuana registration card which may cost $100 or more annually. Each state establishes its own rules for the growing and dispensing of medical marijuana. These states now allow thousands of people to legally purchase a growing variety of marijuana products upon the presentation of these cards or, in some states, the physician’s letter to one of the state-sanctioned dispensaries. It is estimated that 2 1/2 to 3% of the residents of California are now credentialed to buy marijuana legally in what is estimated to be between a 1 1/2 to 2 1/2 billion dollar business. One has only to visit one of the California dispensaries to see how sophisticated this industry is becoming, with a range of newly developed cannabis products; beyond having perhaps a dozen or more different strains of herbal cannabis to choose from, there is a large choice of edible and even topical marijuana medications. The patient who wants to use a pipe, bong or vaporizer will find a large and growing selection to choose from. There now exist a few laboratories equipped to measure the percentage of individual cannabinoids and terpenes, and to provide assurance against contamination with insecticides or fungi.

The rapidly increasing number of patients who are now seeking cannabis as a medicine is fueling a burgeoning medical marijuana enterprise which is becoming increasingly sophisticated. There are the growers who are becoming more adept at breeding new strains which may be more beneficial to patients with particular needs, as for example the present effort to develop strains high in cannabidiol (CBD,a non-psychoactive cannabinoid) . There are now a number of publications aimed at the medical marijuana community, most notably O’Shaughnessy’s, the Journal of Cannabis Clinical Practice, published in San Francisco. The recently formed physicians’ professional organization, the Society of Cannabis Clinicians (SCC), promotes clinical cannabis research.

Despite harassment by the federal authorities, especially in California, all aspects of this alternative medicine which is beginning to look like a new school or philosophy of medicine will continue to grow and become more sophisticated as it is embraced by more and more patients, legally or illegally. This new medicine, bolstered by the fundamental understandings in biology and physiology that have come from the discovery and study of the endogenous cannabinoid signaling system, which might be called “cannabinopathic medicine”, joins other alternative schools of medicine such as naturopathic medicine, homeopathic medicine and osteopathic medicine. Cannabinopathic medicine is being practiced all over this country, openly in the states which have made it legal, and clandestinely in those which have yet to do so. Osteopathic medicine, which was first practiced in the latter part of the 19th century, has now moved so close to allopathic medicine in its training and practice that it has become integrated with modern Western medicine. In the early days of medical marijuana it was assumed that it would become integrated into Western medicine as a new therapeutic; thus the effort which began in 1972 to persuade the federal government to change its Controlled Substances Act Schedule I status to Schedule II as the essential first step toward collecting the kind of data necessary for the FDA’s medicinal drug approval process. While the government has in the past made tentative moves in the direction of accepting the reality of marijuana’s medical capacities, including the now defunct Compassionate IND program and the relatively recent decisions to move synthetic THC (Marinol) from Schedule I to Schedule II, and several years later to Schedule III (less harmful than drugs in Schedules I and II), it has steadfastly refused to release herbal marijuana from its Schedule I restrictions.

Today, even if it were free of its Schedule I chains, its path to legitimacy as a pharmaceutical faces other obstacles. A big one is the availability of funding for the kind of research which would allow it to be presented to the FDA. The cost of this research runs to upwards of $800 million per drug. Pharmaceutical companies do not undertake such costly research unless they have been awarded the 20 year new drug patent and are reasonably sure that, once approved, the drug will sell for the price they will need to charge during that exclusive period to cover these costs and make a profit. The pharmaceutical companies, however, have no interest in herbal marijuana because it cannot be patented. Only in the case of some orphan drugs does the government support these developmental costs. An exception to this rule occurred in the early 1980s when the government provided major funding to a small pharmaceutical company, Unimed, towards its development of a synthetic THC which was called dronabinol (Marinol). The government assumed that with Marinol’s legal availability it would then be possible to assert that there was no longer a need for medicinal marijuana as there was now a commercially available cannabinoid pharmaceutical product. The problem with this strategy became obvious to every patient who tried to substitute Marinol for smoked or ingested marijuana; it simply did not work nearly as well as herbal marijuana. The primary reason that some patients use Marinol today is because it is legal.

The vast majority of people who use cannabis as a medicine must suffer the anxiety, uncertainty, and risk associated with obtaining and using an illegal substance. The responses of physicians, as indicated by patients’ stories, vary a great deal. With the exception of a small minority of physicians, such as those who comprise the Society of Cannabis Clinicians, physicians’ attitudes toward marijuana as a medicine generally range from outspokenly negative to varying degrees of skepticism; a few are hostile or contemptuous, some are indifferent or unconvinced, and a growing number offer at least some encouragement or moral support. Unfortunately, even the most sympathetic are either afraid to do more because of the law or are unable to provide advice because they have been misinformed about cannabis and simply know too little about its therapeutic value. Physicians of a century ago knew much more about cannabis than do contemporary physicians whose education about new drugs comes largely from the pharmaceutical industry. Today’s physicians are often introduced to therapeutic marijuana by their patients, but even those physicians who become educated about this drug may be afraid to recommend what they know or suspect to be the best treatment out of fear that they might lose their reputations, licenses, and careers. Even if marijuana were available as a Schedule II medicine, pharmacies would be reluctant to carry it and physicians would hesitate to prescribe it. Through computerized monitoring, the DEA could know who was receiving prescription marijuana and how much. It could hound physicians who, by its standards, prescribed cannabis too freely or for reasons it considered unacceptable. The potential for harassment would be extremely discouraging. Unlike other Schedule II drugs, such as cocaine and morphine, cannabis has many potential medical uses rather than just a few. Many people would undoubtedly try to persuade their doctors that they had a legitimate claim to a prescription. Doctors would not want the responsibility of making such decisions if they were constantly under threat of discipline by the DEA. Furthermore, many doctors would not consider prescribing cannabis at all because they are victims of the government’s misinformation campaign. Some still believe and promote such hoary myths as the notion that marijuana is addictive or leads to the use of more dangerous drugs.

Despite the growing appreciation of its safety and usefulness as a medicine there is, after more than three decades of effort, little hope that herbal marijuana will soon be integrated into modern Western medicine. And even if it were, there would be enormous problems in controlling the distribution of a controlled medicine which has now become an established and popular Western culture recreational drug The pharmaceutical industry will continue to develop cannabinoid products and the government will make Control Substances Act scheduling accommodations, as they did with Marinol, to make them available as prescription drugs. Some of them will be very useful and a few may, for specific symptoms or syndromes, be more useful than herbal marijuana, but it is unlikely that they will ever displace it; herbal marijuana will always provide more choice, be less expensive and more readily available. Because the commercial success of its cannabinoid products will vary directly with the severity of the prohibition, the pharmaceutical industry will predictably put even more pressure on the government to maintain or even strengthen its prohibition.

However, the realities of human need are incompatible with the demand for a legally enforceable distinction between medicine and all other uses of cannabis. Marijuana simply does not conform to the conceptual boundaries established by 20th century institutions. It is truly a sui generissubstance; is there another relatively benign drug which is capable of heightening many pleasures, has a large and growing number of medical uses and has the potential to enhance some individual human capacities? The only workable way of realizing the potential of this remarkable substance, including its full medical potential, is to free it from the present dual set of regulations – – those that control prescription drugs in general and the special criminal laws that control psychoactive substances. These mutually reinforcing laws establish a set of social categories that strangle its uniquely multifaceted potential. The only way out is to cut the knot by giving marijuana the same status as alcohol – – legalizing it for adults for all uses and removing it entirely from both the medical and criminal control systems.

Perhaps in part because so many Americans have discovered for themselves that marijuana is both relatively benign and remarkably useful, moral consensus about the evil of cannabis is becoming uncertain and shallow. The authorities pretend that eliminating marijuana traffic is like eliminating slavery or piracy, or eradicating smallpox or malaria. The official federal government view is that everything possible has to be done to prevent everyone from ever using marijuana, even as a medicine. But there is also an informal lore of marijuana use that is far more tolerant. Many of the millions of cannabis users in this country not only disobey the drug laws but feel a principled lack of respect for them. They do not conceal their bitter resentment of laws that render them criminals. They believe that many people have been deceived by their government, and they have come to doubt that the “authorities” understand much about either the deleterious or the useful properties of this drug. This undercurrent of ambivalence and resistance in public attitudes towards marijuana leaves room for the possibility of change, especially since the costs of prohibition are so high and rising.

Because multifaceted marijuana is now here to stay as a very useful and safe medicine, as a superior recreational drug, and as an enhancer of a variety of human capacities, this more than 70-year-old destructive prohibition cannot endure much longer. It is reasonable to assume that had there never been a marijuana prohibition, smoked marijuana, because it is both more reliable and easier to titrate, would have displaced Tincture of Cannabis as the cannabinoid medicine of choice. Without prohibition, marijuana would have become as easily accessible as aspirin. It would have provided the first opportunity for herbal marijuana to compete with pharmaceutical products and its success would have assured its place as an integral part of modern allopathic medicine. However, can we now assume that the end of the prohibition against herbal marijuana, which must come sooner or later, will see it regain its rightful place in modern medicine? Given the enormous influence of contemporary big Pharma on the medical establishment and the government, this is not so clear. It is not just a matter of big Pharma losing out on the enormous profits to be made with cannabis in its herbal form, but also, what it would lose from the diminished sales of many of its products which will have to compete with herbal marijuana. Even the cannabinoid products that the pharmaceutical industry has and will continue to develop are unlikely to win many if not most clinical contests on a level playing field with cannabinopathic medicine’s gold standard, herbal marijuana, for which, as a product of nature, there are no exclusive rights..

In the face of the ongoing prohibition cannabinopathic medicine will continue to grow and develop. It will continue to collect data to help it discover new medicinal uses; to develop new strains to more effectively target particular symptoms and illnesses; to generate new modifications of herbal products to facilitate topical application, ingestion and smoking or inhaling; and it will continue to train people in the newest and best ways to use these products. In states which have not legalized the use of cannabis as a medicine, all aspects of the practice of cannabinopathic medicine will continue to be subterranean. In the states which have already made it more or less legally available as a medicine (depending on the comprehensiveness of the list of symptoms and syndromes for which the state allows it to be used as a medicine) cannabinopathic practice continues to be only partially transparent. Because it is unlikely that any state will ever include pre-menstrual syndrome or intractable hiccups, for example, as indications for which cannabis may be useful, patients suffering from these and many other disorders will have to continue to use cannabis covertly or wait until after the prohibition comes to an end as it recently has in Colorado and Washington. This is consistent with my belief that it will be impossible to realize the full potential of this plant as a medicine, not to speak of the other ways in which it is useful, in the setting of this destructive prohibition.

 

Human Marijuana Trials Moving Forward to Determine Medical Benefits

Monday, April 29, 2013 @ 03:04 PM  posted by Teena Liberman

Thousands of medical marijuana patients in the United States rely on the drug to alleviate a multitude of symptoms from cachexia to nerve pain; nevertheless, the Drug Enforcement Administration (DEA) still considers it a Schedule I controlled substance that has no accepted medical use.

Despite this law-enforcement-agency-approved “analysis,” doctors are conducting their own research. In Israel, the Meir Medical Center is recruiting Crohn’s Disease sufferers for a study on the ability of marijuana to treat the inflammatory bowel disease, which affects 400,000-600,000 North Americans.

In San Francisco, for more than five years, doctors at California Pacific Medical Center have been studying the effects of the marijuana compound cannabidiol (CBD) on metastatic cancer cells (i.e., very aggressive tumor cells). In their recently published large-scale animal trial, brain scans revealed the disruption of tumor cells after CBD was used to switch off a specific gene regulator.

These promising results left researchers optimistic and they believe that the findings warrant human trials. They will work to secure funding in the upcoming months for two trial groups, one for brain cancer and the other for breast cancer.

Will these and other studies finally convince our government that science, not myth, should dictate how we approach marijuana?

Source: http://blog.mpp.org/medical-marijuana/human-marijuana-trials-moving-forward-to-determine-medical-benefits/04092013/

Cannabinopathic Medicine: Lester Grinspoon, M.D.’s New Coinage

Thursday, March 14, 2013 @ 09:03 PM  posted by theresa@idrasilrx.com

March 14th, 2013
Posted by Sunil Aggarwal

I am honored and delighted to be able to publish here for the first time a new comprehensive piece written by Dr. Lester Grinspoon, Emeritus Professor of Psychiatry at Harvard Medical School, entitled “Cannabinopathic Medicine”. Dr. Grinspoon started writing this piece in 2012, when I was privileged to read an early draft and give editorial suggestions. He has been looking for a suitable venue for publishing it where it could be read widely. I am grateful that he agreed to allow me to use this blog space to share it. It is approximately 6,000 words and well worth a read.

First, a brief introduction. Dr. Grinspoon, who is in his eighties, is a great physician and researcher who has been a co-author, instructive mentor, and guide of mine. He is known for his pioneering work on the social and medicinal uses of cannabis, but before that, he made significant contributions such as introducing the use of lithium in the treatment of bipolar disorder, the starting of the Harvard Mental Health letter, and many other achievements such as senior psychiatrist at the Massachusetts Mental Health Center in Boston for 40 years, fellow of the American Association for the Advancement of Science and the American Psychiatric Association, founding editor of the The American Psychiatric Association Annual Review, and editor of the Harvard Mental Health Letter for fifteen years, to name a few. It is a wonderful turn of events that Dr. Grinspoon’s home state Massachusetts passed a voter initiative by wide margin to legalize the medicinal use of cannabis for patients with conditions that a physician believes may benefit from its use. That law went into effect this year and now, as of this month, Harvard Medical School-affiliated faculty, in collaboration with the Massachusetts Medical Society, are producing and editing AMA-certified continuing medical education online course series on the medicinal uses of cannabis, vindicating Dr. Grinspoon’s remarkable foresight from over 40 years prior.

 

 

Without further adieu, here is Dr. Grinspoon’s latest piece on cannabis use, where we are going with it as a as society, and where we should be going.

Cannabinopathic Medicine byLester Grinspoon, M.D.

A native of Central Asia, cannabis (hemp) may have been cultivated as long as 10,000 years ago. It was certainly cultivated in China by 4000 BC and in Turkestan by 3000 BC. It has long been used as a medicine in India, China, the Middle East, Southeast Asia, South Africa, and South America. The first evidence of the medicinal use of cannabis is an herbal published during the reign of the Chinese emperor Chen Nung 5000 years ago. It was recommended for malaria, constipation, rheumatic pains, “absentmindedness”, and “female disorders.” Another Chinese herbalist recommended a mixture of hemp, resin, and wine as an analgesic during surgery. In India cannabis had been recommended to quicken the mind, lower fevers, induce sleep, cure dysentery, stimulate appetite, improve digestion, relieve headache, and cure venereal disease. In Africa it was used for dysentery, malaria, and other fevers. Today certain tribes treat snakebite with hemp or smoke it before childbirth. Hemp was also noted as a remedy by Galen and other physicians of the classical and Hellenistic eras, and it was highly valued in medieval Europe. The English clergyman Robert Burton, in his famous work The Anatomy of Melancholy, published in 1621, suggested the use of cannabis in the treatment of depression. The New English Dispensatory of 1764 recommended applying hemp roots to the skin for inflammation, a remedy that was already popular in Eastern Europe. The Edinburgh New Dispensary of 1794 included a long description of the effects of hemp and stated that the oil was useful in the treatment of coughs, venereal disease, and urinary incontinence.

However, in the West cannabis did not come into its own as a medicine until the mid-19th century. The first Western physician to take an interest in cannabis as medicine was W.B. O’ Shaughnessy, a young professor at the Medical College of Calcutta, who had observed its use in India. He gave cannabis to animals, satisfied himself that it was safe, and began to use it with patients suffering from rabies, rheumatism, epilepsy, and tetanus. In a report published in 1839, he wrote that he had found Cannabis Indica, (a solution of cannabis in alcohol, taken orally) to be an effective analgesic. He was also impressed with its muscle-relaxant properties and called it “an anticonvulsive remedy of the greatest value.”

O’Shaughnessy returned to England in 1842 and provided cannabis to pharmacists. Doctors in Europe and the United States soon began to prescribe it for a variety of physical conditions. Cannabis was even given to Queen Victoria for the treatment of her painful pre-menstrual cramps by her court physician. It was admitted to the United States Pharmacopeia in 1850 and commercial cannabis preparations soon became widely distributed through drugstores. Pharmacies welcomed the arrival of this “new” medicine, Cannabis Indica, because at that time their shelves held few truly effective drugs to offer the practitioners of allopathic medicine. As its use became increasingly widespread, clinical reports on cannabis accumulated and by the turn of the century, more than 100 papers were published in the Western medical literature recommending it for various illnesses and discomforts and extolling its remarkably limited toxicity.

The decline in the usage of Cannabis Indica began toward the end of the century. Both the potency of cannabis preparations and its absorption from the bowel were too variable, and individual responses to orally ingested cannabis seemed erratic and unpredictable. Another reason for the neglect of research on the analgesic properties of cannabis was the greatly increased use of opiates after the invention of the hypodermic syringe in the 1850s allowed soluble drugs to be injected for fast relief of pain; cannabis products are insoluble in water and so cannot easily be administered by injection. The end of the 19th century saw the development of such synthetic drugs as aspirin, chloral hydrate, and barbiturates. Two of the most common symptoms for which Cannabis Indica was prescribed were pain and insomnia, and now physicians could prescribe easy-to-take pills of known potency for these two problems, hastening the decline of cannabis as a medicine. But the new drugs had striking disadvantages. More than 1000 people die from aspirin-induced bleeding each year in the United States, and barbiturates are, of course, far more dangerous.

But the Marijuana Tax Act of 1937 was the ultimate death-knell for Cannabis Indica. This law was the culmination of a campaign organized by the Federal Bureau of Narcotics under Harry Anslinger in which the public was led to believe that cannabis, now commonly referred to as marijuana, was addictive and that its use led to violent crimes, psychosis, and mental deterioration; it is now confined to Schedule 1 under the Controlled Substances Act of 1970 as a drug that has a high potential for abuse, lacks accepted medical use, and is unsafe for use even under medical supervision. The film Reefer Madness, made as part of Anslinger’s campaign, may be a joke to the sophisticated today, but it was once regarded as a serious attempt to address a social problem; the atmosphere and attitudes it exemplified and promoted continue to influence our culture, albeit much less so today. The Marijuana Tax Act was not directly aimed at the medical use of cannabis; its purpose was to discourage recreational marijuana smoking. Almost incidentally the law made medical use of cannabis difficult because of the extensive paperwork and fees required of doctors who wanted to prescribe it. The Federal Bureau of Narcotics followed up with “anti-divergent” regulations that contributed to physicians’ disenchantment. Its removal from the United States Pharmacopeia and the National Formulary in 1942 signaled both the end of physicians’ interest in and allopathic medicine’s institutional embrace of cannabis. Furthermore, physicians allowed themselves to become ignorant about this drug as they have, since the mid-1930s, been increasingly exposed along with every other citizen to the deceptive propaganda against marijuana propagated by the United States government and such private organizations as the Partnership for a Drug Free America.

The concept of marijuana as a medicine virtually disappeared for several decades. Then in the 1960s, as large numbers of people began to use marijuana recreationally, claims of its medical utility began to appear, not in the medical literature but in the form of letters to popular magazines like Playboy. Typically these accounts were written by surprised and excited recreational users who had serendipitously discovered that marijuana relieved one or another of a variety of symptoms and syndromes. Over the next several decades, the grapevine word of these rediscovered medical utilities continued to grow. With the advent of the AIDS epidemic and the discovery of marijuana’s ability to reduce the nausea and therefore the threat of the “weight reduction syndrome of AIDS”, this reappearance of the concept of cannabis as a medicine gathered enough momentum to be publicly palpable. It was at this time that public pressure on the government to reconsider its obdurately held position developed in earnest, but with little success to date at the federal level.

There is an important difference in the way cannabis was used as a medicine in the latter
half of the 19th century and the way it has been generally administered since its reemergence as a sub rosa medicine in the mid-20th century. In its earlier iteration it was dispensed orally as an alcoholic solution; now it is primarily taken through the pulmonary system as smoke. The emergence of cannabis as a recreational drug began in the early part of the 20th century and has continued to grow. One of the reasons it has grown to the point where it can now be considered a part of Western culture is its introduction as a smokable drug. A good deal of mystery and uncertainty surrounds the story of the “reefer’s” debut in the United States. It is generally thought that in the early decades of the 20th century the custom of smoking “the weed” in cigarette form traveled with groups of itinerant Mexican workers across the border in the southern and southwestern states; it is now overwhelmingly the mode of administration used by the millions who use it as a medicine or for any other reason today.

This change in the route of administration has greatly enhanced its usefulness as a medicine because it solved the problem of providing the correct dose. One of the major problems that doctors in the 19th century faced with Cannabis Indica was that there were no reliable bioassays at that time and so physicians could never be sure that they had prescribed the correct dose. If too much was prescribed, the patient might experience discomfort in the form of anxiety but this would not be immediately evident because it takes about one to two hours for the effects of orally administered cannabis to be experienced. However, because physicians of the 19th century understood that this was a drug of unusually limited toxicity, they were not as concerned about overdosing as they were about providing an inadequate dose. The major advantage of smoking is the rapidity with which the medicinal effect appears; symptom relief will occur in a matter of minutes. And perhaps even more importantly, this very rapid feedback allows the patient to titrate his own dose for his particular symptom with much more precision than can his physician. He just leisurely puffs until one of two things happens; he either begins to experience symptom-relief or he becomes somewhat high or anxious at which point he stops. It is no longer believed that the smoke from marijuana is harmful to pulmonary or oropharyngeal tissues. But, for those patients who prefer not to smoke, there now is the option of using an instrument called a vaporizer which allows one to inhale the cannabinoids free of the combustion products of the cannabis plant.

In what may be the first attempt to reestablish the place of cannabis in mainstream allopathic medicine, the National Organization for the Reform of Marijuana Laws (NORML) in 1972 petitioned the Bureau of Narcotics and Dangerous Drugs, later renamed the Drug Enforcement Administration (DEA), to transfer marijuana to Schedule II so that the research necessary for the Food and Drug Administration (FDA) approval could be undertaken. Without this approval it cannot be clinically researched nor can it be legally prescribed. As the proceedings continued, other parties joined, including the Physicians Association for AIDS Care. It was only in 1986, after many years of legal maneuvering, that the DEA acceded to the demand for public hearings required by law. During the hearings, which lasted two years, many patients and physicians testified and thousands of pages of documentation were introduced. In 1988 the DEA’s own Administrative Law Judge, Francis L. Young, declared that marijuana in its natural form fulfilled the legal requirement of currently accepted medical use in treatment in the United States. He added that it was “one of the safest therapeutically active substances known to man.” His order that the marijuana plant be transferred to Schedule II was overruled, not by any medical authority, but by the DEA itself, which issued a final rejection of all pleas for reclassification in March 1992.

Meanwhile, growing demand forced the FDA to institute the Individual Treatment IND (commonly referred to as a Compassionate IND) for the use of physicians whose patients needed marijuana. The application process was made enormously complicated, and most physicians did not want to become involved, especially since many believed there was some stigma attached to prescribing marijuana. Between 1976 and 1988 the government reluctantly awarded about a half-dozen Compassionate INDs for the use of marijuana. In 1989 the FDA was deluged with new applications from people with AIDS, and the number granted rose to 34 within the year. In June 1991, the Public Health Service announced that the program would be suspended because it undercuts the Administration’s opposition to the use of illegal drugs. After that no new Compassionate IND’s were granted, and the program was discontinued in March 1992. Four patients are still receiving marijuana under the original program; for everyone else it is at the federal level an outlaw medicine.

Despite its federal illegality, beginning in 1996 with California’s passage of its Proposition 215, 18 states and the District of Columbia have established legislation which makes it possible for patients suffering from a variety of disorders to use the drug legally with a recommendation from a physician.  Unfortunately, because each state arrogates to itself the right to define which symptoms and syndromes may be lawfully treated with cannabis, many patients with legitimate claims to the therapeutic usefulness of this plant must continue to use it illegally and therefore endure the extra layer of anxiety imposed by its illegality.  California and Colorado are the two states in which the largest number of patients for whom it would be medically useful have the freedom to access it legally.  New Jersey appears to be shaping up as one of the most restrictive, and for that reason it is likely that only a small fraction of the pool of patients who would find marijuana to be as or more useful than the invariably more toxic conventional drugs it will displace will be allowed legal access to it.  The framers of the New Jersey legislation may fear what they see as chaos in the distribution of medical marijuana in California and Colorado, a fear born of their concern that the more liberal parameters of medical use adopted in these states have allowed its access to many people who use it for other than strictly medical reasons.

Because so many people are now having an opportunity to observe relatives or friends who are successfully, safely and relatively inexpensively using marijuana as a medicine,  it will not be long before an overwhelming majority of citizens demand the same rights.   There are now six other states working on medical marijuana legislation; this is a reflection of recent polls which show that more than 70% of American citizens now support the legal availability of marijuana as a medicine.  These additional states and their citizens will inadvertently become part of an ongoing large social experiment in how best to deal with the reinvention of the “cannabis as medicine” phenomenon.  Already we have learned a great deal from this ongoing experiment; one of the most important is that the states which have the more restricted and limited medical indications for allowable use of marijuana as a medicine have the largest number of patients who are compelled to use it illegally, while those which are the least restricted with respect to allowable medical indications unintentionally provide it to many people who use it for other purposes.

Shortly after O’ Shaughnessy introduced cannabis as a new medicine, modern Western medicine (allopathic medicine) signaled its acceptance when it was entered into the various Western pharmacopeia in the mid-19th century.  It was expected, certainly by the 1990s, that it would be readmitted as a legitimate medicine, given the mountain of largely anecdotal evidence which establishes both its efficacy and safety,  and its potential (once free of the prohibition tariff) to be much less expensive than pharmaceutical industry products it will replace.  The two major agencies of this resistance to its readmission are the US government and the medical/pharmaceutical establishment.

Today drugs must undergo rigorous, expensive and time-consuming research to win approval by the FDA before they can be marketed as medicines.  The first step made in trying to move the federal government was to petition it to move cannabis from its Schedule I status in the Controlled Substances Act to Schedule II so that it would then be possible to do the kinds of controlled studies essential to the presentation of any new drug to the Food and Drug Administration (FDA) for approval in accordance with the protocol used by the pharmaceutical industry.  As noted above, the first attempt to petition the FDA and DEA to move marijuana to Schedule II was initiated in 1972 and after two decades of hearings and delays the DEA rejected all pleas for reclassification.  Another two decades have passed and, with the exception of a handful of small-to-medium sized randomized controlled trials of smoked cannabis in chronic pain, spasticity, and wasting syndrome, the federal government continues to block the possibility of demonstrating that marijuana could satisfy the FDA criteria for a safe and efficacious addition to the pharmacopeia by continuing to insist, against overwhelming evidence to the contrary, that it is properly placed in Schedule I. In actuality it is now clear that marijuana no more belongs in Schedule I than does aspirin.

The purpose of the FDA testing is to protect the consumer by establishing both safety and efficacy.  First, the drug’s safety (or rather, limited toxicity) is established through animal and then human experiments.  Next, double-blind controlled studies are conducted to determine whether the drug has more than a placebo effect and is more useful than an available drug.  As the difference between drug and placebo may be small, large numbers of patients are often needed in these studies for a statistically significant effect.  Medical and governmental authorities insist that before marijuana is made legally available to patients, this kind of study should be performed for each of the indications for which it is proposed to be used.  At the same time, the government refuses to reconsider its inappropriate assignment of marijuana to Schedule I, therein making it impossible by imposing a tight and heavily controlled monopoly on research-approved cannabis production and distribution to undertake the kind of studies presently demanded by the FDA for its reintegration into modern Western medicine.

But with the accumulation of an enormous amount of anecdotal evidence,  it has now become doubtful whether these FDA rules should apply to marijuana.  There is now little question about its safety.  It has been used for thousands of years by millions of people with very little evidence of significant toxicity.  Similarly, no further double-blind studies are needed to prove marijuana’s efficacy.  Any astute clinician who has some knowledge of the accumulated clinical experience of patients who have used marijuana as a medicine knows that it is efficacious to some degree for many people with various symptoms and syndromes.  Anecdotal evidence commands much less attention than it once did, yet it is the source of much of our knowledge of synthetic medicines as well as plant derivatives.  Controlled experiments were not needed to recognize the therapeutic potential of chloral hydrate, barbiturates, aspirin, curare, insulin, or penicillin— pharmaceuticals introduced  before the double-blind controlled study was invented.

Anecdotes present a problem that has always haunted medicine: the anecdotal fallacy or the fallacy of enumeration of favorable circumstances (counting the hits and ignoring the misses).  If many people suffering from, say, muscle spasms caused by multiple sclerosis take marijuana and only a few get much better relief than they could get from conventional drugs, those few patients would stand out and come to our attention.  They and their physicians would understandably be enthusiastic about marijuana and might proselytize for it.  These people are not dishonest, but they are not dispassionate observers.  Therefore, some may regard it as irresponsible to suggest on the basis of anecdotes that cannabis may help people with a variety of disorders.  That might be a problem if cannabis were a dangerous drug but, in fact, it is remarkably safe.  Even in the unlikely event that only a few people with multiple sclerosis find that it provides relief from muscle spasm, it can be argued that cannabis should be available to them because it costs so little to produce and the risks are so small.

The benefits of any medicine must be weighed against the risks.  Fortunately, there is unusually good evidence on the potential health hazards of marijuana—far better than the evidence on most prescription drugs.  Not only has cannabis been used for thousands of years by many millions of people, but there is much recent research on its safety inspired by the federal government’s interest in discovering toxic effects to justify its policy of prohibition.  The potential dangers of  marijuana when taken for pleasure and its possible usefulness as a medicine are historically and practically interrelated issues: historically, because the arguments used to justify the suppression of recreational use have had a disastrous influence on views of its medical potential; practically, because it is more likely to be safe as a medicine if it is relatively safe as a euphoriant.  As the evidence makes it increasingly clear that cannabis is relatively benign, it is becoming more and more difficult to deny that a risk-benefit analysis now satisfies all requirements for medical use.

Penicillin was discovered in 1929, but the discovery was ignored by the medical establishment for more than a decade until the first clinical trial with six patients who suffered from a variety of infections; all were successfully treated.  After this debut in 1941, penicillin rapidly earned the reputation as the wonder drug of the 1940s.  It earned that reputation for three reasons: it was remarkably non-toxic, even at high doses; it could be produced inexpensively on a large scale; and it was extremely versatile, acting against microorganisms that cause a great variety of diseases, from pneumonia to syphilis.  In all three respects cannabis suggests parallels: it is remarkably safe; once it is free of the prohibition tariff it will be inexpensive; and it is effective against a large number of symptoms and syndromes.  Penicillin did not undergo modern FDA approval scrutiny because its safety and efficacy had been well established by the time the FDA adopted the present protocol for approving new drugs.  Marijuana is now in the same position vis-à-vis the FDA; it has accumulated, both from recreational and medicinal use, more than enough evidence of its safety and efficacy.

As its reputation as a medicine grew, so did the demand for legal access.  In 1996, California became the first state to provide legal (as far as the state was concerned)  access for specified signs and symptoms and under controlled conditions.  Over the next 15 years 16 other states and the District of Columbia followed suit, but the defined parameters of availability, particularly the rules for distribution and the medical reasons for which use would be allowed, have generally become more constricted.  In these states the only involvement with the medical establishment is the requirement that the patient receive a note from a physician stating that he believes the patient’s condition would be helped by cannabis; these notes allow the patient to receive a state-issued medical marijuana registration card which may cost $100 or more annually.  Each state establishes its own rules for the growing and dispensing of medical marijuana.  These states now allow thousands of people to legally purchase a growing variety of marijuana products upon the presentation of these cards or, in some states, the physician’s letter to one of the state-sanctioned dispensaries.  It is estimated that 2 1/2 to 3% of the residents of California are now credentialed to buy marijuana legally in what is estimated to be between a 1 1/2 to 2 1/2 billion dollar business.  One has only to visit one of the California dispensaries to see how sophisticated this industry is becoming, with a range of newly developed cannabis products; beyond having perhaps a dozen or more different strains of herbal cannabis to choose from, there is a large choice of edible and even topical marijuana medications.  The patient who wants to use a pipe, bong or vaporizer will find a large and growing selection to choose from.  There now exist a few laboratories equipped to measure the percentage of individual cannabinoids and terpenes, and to provide assurance against contamination with insecticides or fungi.

The rapidly increasing number of patients who are now seeking cannabis as a medicine is fueling a burgeoning medical marijuana enterprise which is becoming increasingly sophisticated.  There are the growers who are becoming more adept at breeding new strains which may be more beneficial to patients with particular needs, as for example the present effort to develop strains high in cannabidiol (CBD,a non-psychoactive cannabinoid) .  There are now a number of publications aimed at the medical marijuana community, most notably O’Shaughnessy’sthe Journal of Cannabis Clinical Practice, published in San Francisco.  The recently formed physicians’ professional organization, the Society of Cannabis Clinicians (SCC), promotes clinical cannabis research.

Despite harassment by the federal authorities, especially in California, all aspects of this  alternative medicine which is beginning to look like a new school or philosophy of medicine will continue to grow and become more sophisticated as it is embraced by more and more patients, legally or illegally.  This new medicine, bolstered by the fundamental understandings in biology and physiology that have come from the discovery and study of the endogenous cannabinoid signaling system, which might be called “cannabinopathic medicine”, joins other alternative schools of medicine such as naturopathic medicine, homeopathic medicine and osteopathic medicine.  Cannabinopathic medicine is being practiced all over this country, openly in the states which have made it legal, and clandestinely in those which have yet to do so.  Osteopathic medicine, which was first practiced in the latter part of the 19th century, has now moved so close to allopathic medicine in its training and practice that it has become integrated with modern Western medicine.  In the early days of medical marijuana it was assumed that it would become integrated into Western medicine as a new therapeutic; thus the effort which began in 1972 to persuade the federal government to change its Controlled Substances Act Schedule I status to Schedule II as the essential first step toward collecting the kind of data necessary for the FDA’s medicinal drug approval process.  While the government has in the past made tentative moves in the direction of accepting the reality of marijuana’s medical capacities, including the now defunct Compassionate IND program and the relatively recent decisions to move synthetic THC (Marinol) from Schedule I to Schedule II, and several years later to Schedule III (less harmful than drugs in Schedules I and II), it has steadfastly refused to release herbal marijuana from its Schedule I restrictions.

Today, even if it were free of its Schedule I chains, its path to legitimacy as a pharmaceutical faces other obstacles.  A big one is the availability of funding for the kind of research which would allow it to be presented to the FDA.  The cost of this research runs to upwards of $800 million per drug.  Pharmaceutical companies do not undertake such costly research unless they have been awarded the 20 year new drug patent and are reasonably sure that, once approved, the drug will sell for the price they will need to charge during that exclusive period to cover these costs and make a profit.  The pharmaceutical companies, however, have no interest in herbal marijuana because it cannot be patented. Only in the case of some orphan drugs does the government support these developmental costs.  An exception to this rule occurred in the early 1980s when the government provided major funding to a small pharmaceutical company, Unimed, towards its development of a synthetic THC which was called dronabinol (Marinol).  The government assumed that with Marinol’s legal availability it would then be possible to assert that there was no longer a need for medicinal marijuana as there was now a commercially available cannabinoid pharmaceutical product.  The problem with this strategy became obvious to every patient who tried to substitute Marinol for smoked or ingested marijuana; it simply did not work nearly as well as herbal marijuana.  The primary reason that some patients use Marinol today is because it is legal.

The vast majority of people who use cannabis as a medicine must suffer the anxiety, uncertainty, and risk associated with obtaining and using an illegal substance.  The responses of physicians, as indicated by patients’ stories, vary a great deal.  With the exception of a small minority of physicians, such as those who comprise the Society of Cannabis Clinicians, physicians’ attitudes toward marijuana as a medicine generally range from outspokenly negative to varying degrees of  skepticism; a few are hostile or contemptuous, some are indifferent or unconvinced, and a growing number offer at least some encouragement or moral support.  Unfortunately, even the most sympathetic are either afraid to do more because of the law or are unable to provide advice because they have been misinformed about cannabis and simply know too little about its therapeutic value.  Physicians of a century ago knew much more about cannabis than do contemporary physicians whose education about new drugs comes largely from the pharmaceutical industry.  Today’s physicians are often introduced to therapeutic marijuana by their patients, but even those physicians who become educated about this drug may be afraid to recommend what they know or suspect to be the best treatment out of fear that they might lose their reputations, licenses, and careers.  Even if marijuana were available as a Schedule II medicine, pharmacies would be reluctant to carry it and physicians would hesitate to prescribe it.  Through computerized monitoring, the DEA could know who was receiving prescription marijuana and how much.  It could hound physicians who, by its standards, prescribed cannabis too freely or for reasons it considered unacceptable.  The potential for harassment would be extremely discouraging.  Unlike other Schedule II drugs, such as cocaine and morphine, cannabis has many potential medical uses rather than just a few.  Many people would undoubtedly try to persuade their doctors that they had a legitimate claim to a prescription.  Doctors would not want the responsibility of making such decisions if they were constantly under threat of discipline by the DEA.  Furthermore, many doctors would not consider prescribing cannabis at all because they are victims of the government’s misinformation campaign.  Some still believe and promote such hoary myths as the notion that marijuana is addictive or leads to the use of more dangerous drugs.

Despite the growing appreciation of its safety and usefulness as a medicine there is, after more than three decades of effort, little hope that herbal marijuana will soon be integrated into modern Western medicine.  And even if it were, there would be enormous problems in controlling the distribution of a controlled medicine which has now become an  established and popular Western culture recreational drug  The pharmaceutical industry will continue to develop cannabinoid products and the government will make Control Substances Act scheduling accommodations, as they did with Marinol, to make them available as prescription drugs.  Some of them will be very useful and a few may, for specific symptoms or syndromes, be more useful than herbal marijuana, but it is unlikely that they will ever displace it; herbal marijuana will always provide more choice, be less expensive and more readily available.  Because the commercial success of its cannabinoid products will vary directly with the severity of the prohibition, the pharmaceutical industry will predictably put even more pressure on the government to maintain or even strengthen its prohibition.

However, the realities of human need are incompatible with the demand for a legally enforceable distinction between medicine and all other uses of cannabis.  Marijuana simply does not conform to the conceptual boundaries established by 20th century institutions.  It is truly a sui generissubstance; is there another relatively benign drug which is capable of heightening many pleasures, has a large and growing number of medical uses and has the potential to enhance some individual human capacities?  The only workable way of realizing the potential of this remarkable substance, including its full medical potential, is to free it from the present dual set of regulations – – those that control prescription drugs in general and the special criminal laws that control psychoactive substances.  These mutually reinforcing laws establish a set of social categories that strangle its uniquely multifaceted potential.  The only way out is to cut the knot by giving marijuana the same status as alcohol – – legalizing it for adults for all uses and removing it entirely from both the medical and criminal control systems.

Perhaps in part because so many Americans have discovered for themselves that marijuana is both relatively benign and remarkably useful, moral consensus about the evil of cannabis is becoming uncertain and shallow.  The authorities pretend that eliminating marijuana traffic is like eliminating slavery or piracy, or eradicating smallpox or malaria.  The official federal government view is that everything possible has to be done to prevent everyone from ever using marijuana, even as a medicine.  But there is also an informal lore of marijuana use that is far more tolerant.  Many of the millions of cannabis users in this country not only disobey the drug laws but feel a principled lack of respect for them.  They do not conceal their bitter resentment of laws that render them criminals.  They believe that many people have been deceived by their government, and they have come to doubt that the “authorities” understand much about either the deleterious or the useful properties of this drug.  This undercurrent of ambivalence and resistance in public attitudes towards marijuana leaves room for the possibility of change, especially since the costs of prohibition are so high and rising.

Because multifaceted marijuana is now here to stay as a very useful and safe medicine, as a superior recreational drug, and as an enhancer of a variety of human capacities, this more than 70-year-old destructive prohibition cannot endure much longer. It is reasonable to assume that had there never been a marijuana prohibition, smoked marijuana, because it is both more reliable and easier to titrate, would have displaced Tincture of Cannabis as the cannabinoid medicine of choice.  Without prohibition, marijuana would have become as easily accessible as aspirin.  It would have provided the first opportunity for herbal marijuana to compete with  pharmaceutical products and its success would have assured its place as an integral part of modern allopathic medicine.  However, can we now assume that the end of the prohibition against herbal marijuana, which must come sooner or later, will see it regain its rightful place in modern medicine?   Given  the enormous influence of contemporary big Pharma on the medical establishment and the government, this is not so clear.  It is not just a matter of big Pharma losing out on the enormous profits to be made with cannabis in its herbal form, but also, what it would lose from the diminished sales of many of its products which will have to compete with herbal marijuana.  Even the cannabinoid products that the pharmaceutical industry has and will continue to develop are unlikely to win many if not most clinical contests on a level playing field with cannabinopathic medicine’s gold standard, herbal marijuana, for which, as a product of nature, there are no exclusive rights..

In the face of the ongoing prohibition cannabinopathic medicine will continue to grow and develop.  It will continue to collect data to help it discover new medicinal uses; to develop new strains to more effectively target particular symptoms and illnesses; to generate new modifications of herbal products to facilitate topical application, ingestion and smoking or inhaling; and it will continue to train people in the newest and best ways to use these products.  In states which have not legalized the use of cannabis as a medicine, all aspects of the practice of cannabinopathic medicine will continue to be subterranean. In the states which have already made it more or less legally available as a medicine (depending on the comprehensiveness of the list of symptoms and syndromes for which the state allows it to be used as a medicine) cannabinopathic practice continues to be only partially transparent.  Because it is unlikely that any state will ever include pre-menstrual syndrome or intractable hiccups, for example, as indications for which cannabis may be useful, patients suffering from these and many other disorders will have to continue to use cannabis covertly or wait until after the prohibition comes to an end as it recently has in Colorado and Washington.  This is consistent with my belief that it will be impossible to realize the full potential of this plant as a medicine, not to speak of the other ways in which it is useful, in the setting of this destructive prohibition.

 

CBD: Expensive, Very Expensive – or Free?

Tuesday, October 9, 2012 @ 06:10 PM  posted by theresa@idrasilrx.com

By David Malmo-Levine

CANNABIS CULTURE – A company in Israel announced recently that it is the first to develop a strain of cannabis low in THC and high in cannabidiol (CBD) using the natural breeding process with no unnatural genetic modifications.

While this claim is misleading regarding the novelty of such a strain, I believe it was truthful regarding the process by which such a strain was created. But is the origin of high-CBD strains genetic, or is it a factor of the environment? Probably both.

The Announcement

From Public Radio International:

[A]n Israeli company claims it is the first to develop a strain of the cannabis plant that contains almost no THC at all. … The new cannabis strain took about 3 years to develop through cross-breeding, according to Zach Klein of Tikkun Olam. There was no genetic engineering involved, he said. The new strain is all natural. “Avidekel” is the nickname for the CBD strain, Klein said.”

I don’t believe this company is the “first to develop a strain of the cannabis plant that contains almost no THC at all.” This 2005 article from Cannabis Culturementions GW Pharmaceutical growing “virtually mono-cannabinoidic plants that produce high percentages of these target cannabinoids: THC, CBD, THC-V, CBC, CBD-V, CBG or CBN.”

This lab report indicates that “cannatonic #6″ was high in CBD with hardly any THC, perhaps also indicating that the “cannatonic” strain is either unstable, genetically producing different cannabinoid results with each plant, or getting different results under different growing conditions.

17% of Harborside Healthcenter’s tested cannabis rated at or above 1% CBD, with three strains in the 14 to 16% range of CBD.

Not to mention that nearly every single industrial hemp variety ever created contains almost no THC at all. For example, this paper written in 1996 lists many industrial hemp varieties with next to no THC and 4% to 5% CBD.

Though Tikkun Olam’s claims of originality are false, I believe the company was correct in describing the breeding process as the method of designing high-CBD strains, but there is some debate as to whether the plant’s characteristics are due to genetics or the environment. I think it is probably both.

Famous breeder David Watson (AKA “Sam Skunkman”) said he doesn’t “believe that soil or light or anything else will increase the CBD level. CBD is controlled by the genetics of the plant, period.” Perhaps what he means to say is that the maximum levels of CBD are controlled by genetics, but according toHillig and Mahlberg, the levels can dip when all kinds of factors are increased or decreased.

It’s possible these factors are also at play during the selection process, and have subtle or not-so-subtle effects on the breeding process itself. I’m not a geneticist, but what I do know is that there’s ample evidence of low-THC, high-CBD strains all over the place, some that have existed before the invention of genetic modification. That means, obviously, genetically modification is not required to produce these strains. It is as easy as grabbing some industrial hemp seeds, growing them out and selecting for high CBD.

Dr. Frankel

Dr. Allan Frankel, a Santa Monica MD who works with Green Bridge Medical, wrote a series of blogs blasting activists concerned about GM cannabis, as a response to a discussion (including myself, Dr. Frankel, and lawyer Letitia Pepper) on an email list:

http://www.greenbridgemed.com/2012/07/07/highless-marijuana-or-rich-cbd/
http://www.greenbridgemed.com/2012/07/08/there-is-no-gmo-cannabis/
http://www.greenbridgemed.com/2012/07/08/highless-and-gmo-marijuana-nope…
http://www.greenbridgemed.com/2012/07/08/please-get-our-facts-straight-t…

In his posts, Dr. Frankel argues that there “is no GMO cannabis”, and seems to confuse my opinion with Letitia Pepper’s. As stated above, I believe you can get low-THC, high-CBD from normal, non-GMO breeding methods, or from most industrial hemp. I do not think these strains are a threat or a conspiracy, or ineffective medicinally, and I don’t have a problem with what’s going on in Israel.

Though I don’t believe that GMO cannabis currently exists (as Letitia does), I believe there may be such a creation in the works, and that a ban on genetically modified cannabis would be a good thing.

Right now, there are projects ongoing to genetically modify all useful drug plants, and evidence that cannabis is a likely candidate – for proprietary reasons.

The first mention of the possibility of cannabis being genetically modified I could find was cited in a document leaked to Cannabis Culture back in 2000, which read, in part:

Cannabis seeds from Monsanto are almost definitely genetically engineered. Genetically engineered plants can be patented, and it is in Monsanto’s best interest to hold a patent on any seed they sell. Seed patents ensure that companies like Monsanto can continue to profit from seeds from year to year, as farmers are legally bound to buy patented seeds from the patent holder rather than simply store them from the last year’s crop.

In 2009, the University of Minnesota issued a news release suggesting that researchers were close to “engineering” a “recognizable, drug-free Cannabis plant”:

In a first step toward engineering a drug-free Cannabis plant for hemp fiber and oil, University of Minnesota researchers have identified genes producing tetrahydrocannabinol (THC), the psychoactive substance in marijuana. Studying the genes could also lead to new and better drugs for pain, nausea and other conditions.

And in 2010, one of the USA’s leading farming organizations “passed a bizarre new policy statement in support of industrial hemp farming, but only if it is genetically modified (GMO) and retains cannabis prohibition with very heavy law enforcement.” The National Grange of the Order of Patron of Husbandry, known simply as “The Grange”, stated:

The National Grange supports research, production, processing and marketing of industrial hemp as a viable agricultural activity. We do not in any way support or condone the growth or use of marijuana as a hallucinogen.

“We support strict enforcement of all laws that currently ban the production and sale of marijuana or that classify all species of cannabis as a Class 1 controlled substance in the US. We oppose amending these laws as the primary means of promoting industrial hemp production.
Instead we urge further research and application of existing biotechnology techniques to develop genetically modified industrial hemp that will be biologically incompatible with all other forms of cannabis or marijuana.

We further urge that genetically modified industrial hemp contain distinct chemical markers that will quickly and easily identify industrial hemp varieties using low cost and accurate on-site testing methods for the purpose of contract compliance, law enforcement and as evidence in court.”

While none of this is proof that GM cannabis exists, the fact that other drug plants are routinely subjected to GM, that cannabis is a major – if not the major – cash crop on planet earth, and that GM cannabis is being discussed repeatedly, is evidence that GM cannabis is likely in the future.

What Does CBD Do?

What exactly does CBD do? According to this paper from the International Hemp Association:

CBD shows no psychotropic effects, but some clinically relevant effects have been found. Among them are anticonvulsant effects in epileptics (Cunha 1980) and antidystonic effects in movement disorder patients (Consroe 1986). Some properties resemble those of THC, e.g., some effects on the immune system (Watzl 1991), other properties differ from THC, e.g., the electrophysiological properties (Turkanis 1981), others show distinct contrary effects, e.g. some effects on the heart (Nahas 1985). Of interest in this context is the action of CBD on the psyche. There are sleep-inducing (Carlini 1981), anxiolytic and anti-psychotic effects, as well as an antagonism of the psychotropic effects of THC. High doses of THC can induce anxiety, panic reactions and functional psychotic states. Zuardi et al. (1997) found a significant reduction of anxiety in a model of speech simulation, with 300 mg CBD comparable to 10 mg of the sedative diazepam. The same working group treated a young schizophrenic man who was admitted to a hospital because of aggressive behavior, self-injury, incoherent thoughts and hallucinations, for four weeks with doses up to 1,500 mg CBD. All symptoms improved impressively with CBD, so that the improvement could not solely be attributed to an anxiolytic effect. …  In a study of Zuardi et al. (1982), eight volunteers received high oral doses of THC (0.5 mg THC per kg body weight, about 35 mg), or this dose plus twice the dose of CBD in a double-blind design. The study demonstrated that CBD blocked the anxiety produced by THC. This inhibition was extended to the marijuana-like effects and other alterations caused by THC.

There is also data showing CBD’s effectiveness in helping those suffering from schizophrenia, though it may not be good for glaucoma patients.

Apparently CBD can be given in massive doses with no side effects and becomes very effective as an anti-psychotic when given in these doses.

Last, but certainly not least, CBD appears to shrink tumors.

It is of great value to have low-THC, high-CBD medicine, since many people don’t want to get high (or don’t want to get too high) but want to consume cannabinoids, so my hat is off to the Israelis of Tikkun Olam. Good job! Well done!

CBD in Industrial Hemp

According Tikkun Olam’s website, they do not charge for those who cannot afford their cannabis. Unfortunately, those in Canada and the United States who wish to buy high-CBD cannabis products are faced with high prices for the dried herb or the seeds. One eighth of “Cannatonic” can run as high as $60 and the seeds can cost around $94 per 10 seeds ($157 for feminized seeds), if they’re available at all.

Lucky for us Canadians, there is another option. Industrial hemp is growing all over Canada:

In 2003, over 2700 hectares (6700 acres) were grown across Canada , mostly concentrated on the Prairies. In 2010 it was estimated that 25,000 were grown. Hemp has been grown with success from coast–to–coast.

(See more here.)

And this hemp is all rich in CBD, according to every source I can find. Industrial hemp THC to CBD ratios are usually 1/20.

More here:

In industrial hemp, CBD is the predominant cannabinoid and often occurs in a CBD/THC ratio of more than 8:1.

And here:

Dr. Mahlberg went on to point out that an extraction from industrial hemp using a deceptive procedure found on the Internet will result in a sludge containing many noxious elements and very little THC. Of course the preponderant cannabinoid in this sludge will be CBD.

Canadian aren’t forced to order any special “cannatonic” high-CBD seeds to get lots of CBD medicine, they just have to wander into any industrial hemp field in the fall before harvest with some ice and some buckets and some water and walk out with a ball of high CBD hash the size of your head. Illegal? Yes. But free. There are even fallow hemp fields from the year before that the farmer probably wouldn’t mind (or wouldn’t notice) you doing this with. It matters not that industrial hemp is only 6% CBD and these Israeli strains (or the California high-CBD strains) are 15% or 20% CBD. You can only grow a few of those “medicinal” plants but you can get access to acres of industrial hemp, so you end up getting much more CBD with industrial hemp over-all. Like I said before, industrial hemp CBD is a waste product which is being thrown-out by the tonne every year when it could be harvested for tumor-shrinking (in this post Fukushima world). That’s the real story nobody is talking about, but everyone should be talking about.

If people wish to experiment with crossing their high THC varieties with viable high-CBD industrial hemp seeds, there are some available here for a very reasonable cost: $5 for what appears to be over 20 seeds.

This research paper says you can cross high-THC strains with high-CBD strains to get a mixture of both together.

Whatever you do, remember that even low-THC industrial hemp is illegal to grow in the US under almost all circumstances, and illegal to grow in Canada unless you have ten acres, no criminal record, and you fill out a whack of forms. If they catch you, the authorities will still treat you as if you were growing that nasty THC stuff.

Concept Sheet Development for Cell Line Activity and Animal Model Pharmacokinetics for European Agency Review to be Initiated in 4Q

COLORADO SPRINGS, Colo., Sep 24, 2012 (BUSINESS WIRE) — Cannabis Science (nasd otc:CBIS), a pioneering U.S. Biotech Company developing pharmaceutical products for global public health challenges, is pleased to announce preclinical investigations being initiated in Europe for Squamous/Basal Cell carcinomas and Kaposi’s sarcoma based on inhibition of carcinogenicity utilizing cannabinoids that have been demonstrated in recent studies to significantly affect tumor necrosis.

cannabis science cancer research The company is entertaining entrance into a number of agreements with academic and private sector clinical research organizations that will facilitate initial studies to demonstrate scientific merit of CSTATI-1 and CS-S/BCC-1 that will predictably translate to human studies within the coming year, as clinical options for this patient population remain limited and the etiology of both aggressive squamous/basel cell carcinomas and Kaposi’s sarcoma is poor in immune compromised populations, comparative to other skin cancers.

“To match our U.S. efforts, we are aggressively pursuing institutional investigations abroad to take advantage of the significant expertise demonstrated in many academic research centers on cannabinoids to further our clinical investigation platform,” said Dr. Robert Melamede, President & CEO of Cannabis Science Inc., “we expect to generate from these collaborations a robust portfolio of preclinical data that supports the wide range of our scientific premises on the utility of cannabinoids for aggressive cancers for patients in desperate need of innovative clinical alternatives.”

The Company will update the public and its shareholders of the progress as peer-reviewed publication of the results of these preclinical investigations are made public.

About CS-S/BCC-1
Cannabis Science is currently working to develop preclinical investigations of CS-S/BCC-1 treatment of basal and squamous cell carcinomas.

About CS-TATI-1
Data published in March by researchers at the Mount Sinai School of Medicine found that cannabinoids inhibit TAT induced migration to TAT via cannabinoid 2 receptors (CB2). Funding for the Mount Sinai study was provided by a National Institutes of Health (NIH) Clinical and Translational Science Award Grant. Cannabis Science’s research of CS-TATI-1 will be targeted to newly diagnosed patients infected with drug resistant virus, treatment experienced patients with drug-resistant HIV strains, and those intolerant of currently available therapies. Cannabis Science will be pursuing a wide range of NIH based Federal Research Programs such as RO1′s, PO1′s and SBIRS which exist to support preclinical development of target validation and proof of concept studies. Cannabis Science will be pursing implementation of these studies through collaborations with leading scientific institutions. Cannabis Science will also be pursuing other clinical research collaborations including the AIDS Clinical Trials Groups (ACTG), the Canadian AIDS Trial Network (CATN) and the European AIDS Trial Network (EATN).

Source: cannabisscience.com

How Cannabis Traversed The Planet

Wednesday, October 3, 2012 @ 07:10 PM  posted by theresa@idrasilrx.com

Around the World In 80 Puffs – How Cannabis Spread Across The World

By Brian

In a world where cannabis is the one of the most widely used recreational drugs, it’s worth considering how cannabis has become so wide spread across the earth. Few people may even consider the fact that cannabis is not even native to the vast majority of the countries in which it is smoked and in most cases, considered illegal.

This pervasive little plant has achieved such widespread notoriety not because it has invaded countries like some kind of triffid creature, but because it has been cultivated for a massive variety or reasons throughout human history. Cannabis has been traded and reaped much like any other herb and here we look at how and why it navigated our globe.

China

Almost as far back as human history itself has been recorded there has been documentation of cannabis use for medicinal purposes. Used in treatment for a range of ailments from gout to constipation and even malaria the use of cannabis in medicinal practice can actually be tracked as far into antiquity as 2800B.C. Furthermore this was no isolated chapter in human history…

India

While documented use of cannabis for medicinal purposes started in China, there are clues present that suggest that it is in Western Asian in which we can find the roots of cannabis. The first documentation of a cannabis based remedy in India may only date back to around 1000BC, but the manner in which the plant seemed to haphazardly stray across the Asian continent suggests a far earlier human influence than even China could document.

Ancient Asian Colonisation

The first great migrations out of Africa (the birthplace of man) can only really be traced through fossil records and conjecture, but what is apparent is that swathes of early humans headed through North East Africa, Western Asia and onwards into the East. With them they brought primitive tools, animals and plants.

One such plant that seems to have originated in Western Asia and been used for shamanic rituals was the cannabis plant and it prospered due to the nomadic nature of man, who carried it across the continent in its many diverse varieties.

Africa & Eastern Europe

Some speculation suggests that cannabis was spread to Africa centuries ago but it was not until cannabis in its medicinal guise began to spread west from Asia in 500BC that there was any solid documentation of its use. Once again it was used for a wide variety of ailments and in an often ritualistic fashion. It was in this time that this Asian influence also began to sweep over Eastern Europe as new medicines were sought far and wide.

Britain & the West

It would take more than a century for cannabis in its medical form to make its way into the Western world. In fact it took until the 1800′s before this was even considered, having been utilised for industry since as early as the 15th century. A modern renaissance in pursuit of herbal medicines brought the potential uses of cannabis into France, Spain, and Britain. In fact Britain for a time quite emphatically embraced cannabis as a form of medication for many ailments.

These medical seeds where germinated in Britain was for a wide range of ailments from chronic back-pain to head-aches and insomnia. It is also alleged that Queen Victoria was prescribed cannabis as a pain-killer by her physician.

It was however most predominantly the industrial uses that finally took cannabis full circle around the globe into the new world…

The United States of America

In the infancy of the United States the need for quality resources for housing, animal feed, textiles and more where apparent and hemp which had already been used widely throughout Europe was an ideal solution.

In the early days of independence, presidents and dignitaries alike promoted the use of hemp widely as it provided for a wide range of industries, from animal feed to ship rigging. In addition it was an easily renewable resource that also allowed year round crop rotation due to the rejuvenating effect it had on farmed soils.

In fact it was so important that Thomas Jefferson and George Washington actively promotedgrowing cannabis and developing new methods of harvesting to make America’s cannabis farming stronger.

As a medicine, cannabis was widely tested in the US around the same time that this dawned in Western Europe.

The Banning of Cannabis

In the years that followed however, cannabis would become increasingly marginalised. By the turn of the 20th century more proficient medicines were available and views of cannabis as an intoxicant spread leading to its decline in the western world in particular.

The hemp trade was also severely damaged by powerful slander campaigns based on this ‘intoxication’ funded by the rival lumber industries.

Perhaps however the sun might rise again on cannabis and hemp as we just weren’t ready for it. Already medicinal cannabis is being utilised in the US for the treatment of a range of ailments. Furthermore, with a stronger understanding of the damage that the logging industry is doing to our planet and the apparent renewable benefits of hemp, it may only be a matter of time before things turn around once again.

SAN DIEGO, Oct. 2, 2012 /PRNewswire/ – Medical Marijuana, Inc. (OTC: MJNA), a leading hemp industry innovator and its CanChew Biotechnologies portfolio company are pleased to announce the planned introduction of their CanChew CBD chewing gum product line with a free market trial offer for patients suffering from MS Spasticity, Cancer Pain, and Neuropathic Pain.  This market trial offer will begin October 15, 2012 and will be managed by CanChew Directors; Dr. George Anastassov, Dr. Philip A. Van Damme, and Production Specialist Lekhram Changoer, in cooperation with two U.S. healthcare industry associations: Patients Out of Time of Virginia and the American Cannabis Nurses Association of Oregon.

CanChew does not contain THC, therefore it does not contain any of the psychoactive properties which may impact the neurological balance of a patients mind, or the “high” feeling. Instead, its key active ingredient is a hemp-based, high concentrate CBD oil made available by Medical Marijuana, Inc.’s state-of-the-art extraction technology.  Several ground breaking studies including those highlighted in the September 18, 2012 San Francisco Chronicle article, “Pot compound seen as tool against cancer” as well as at Project CBD, have shown that non-psychoactive CBD wellness products may provide powerful relief for pain and anxiety sufferers, but without the euphoric effects caused by THC. Please click here for more CDB studies: http://www.medicalmarijuanainc.com/index.php/research.

The CBD health and wellness industry is estimated by MJNA to be a $5 billion market. According to BCC Research and Market Forecasting, the global market for pain management pharmaceuticals and devices amounted to $19.1 billion in 2008 and is expected to increase to $32.8 billion in 2013. The compound annual growth rate (CAGR) for the 5-year period is projected at 11.5%.

Starting on October 15, 2012, prospective patients will be able to log into a dedicated website and answer questions on a health history survey to determine their eligibility for participation in the market trial, which will begin by November 15, 2012.  Patients who qualify for the trial will receive a minimum one-month supply of the CBD chewing gum, which contains approximately 8-10 milligrams of CBD per piece and will be blister packed in packages of 8 and 32 pieces. Patients will provide specific feedback to the Company regarding usage and experience. While the company has been underway with clinical development for many months, it expects to launch human Clinical trials for this product and other CBD containing products by the end of 2013. CanChew Biotechnologies expects to launch over-the-counter retail sales of the product in early 2013.

“We’re very excited about this new product and the potential it offers to people suffering from pain and many other ailments. While we originally targeted product sales for October of this year, we decided this interim market launch would provide us with valuable patient feedback and put us in a better position for our full blown national and international launch in early 2013,” stated Ted Caligiuri, Interim President of Medical Marijuana, Inc.

About CanChew Biotech
CanChew® is a unique, socially acceptable, patient friendly, taste masked and convenient delivery format for delivery of cannabis/cannabinoid(s) based pharmaceuticals. The delivery of these medications via the oral mucosa provides for rapid and near complete absorption directly into the systemic circulation. This leads to rapid onset of effects and increased bioavailability. Pre-systemic metabolism is thus avoided. This system of delivery offers clearly improved economic opportunities compared to alternative drug delivery routes. For more information visit: http://www.canchewbiotech.com.

About Medical Marijuana, Inc.
Our mission is to be the premier hemp industry innovators, leveraging our team of professionals to source, evaluate and purchase value-added companies and products, while allowing them to keep their integrity and entrepreneurial spirit. We strive to create awareness within our industry, develop environmentally friendly, economically sustainable businesses, while increasing shareholder value.

Medical Marijuana Inc. does not grow, sell or distribute any substances that violate United States Law or the controlled substance act.

For more information, please visit the company’s website at: www.MedicalMarijuanaInc.com

FOOD AND DRUG ADMINISTRATION (FDA) DISCLOSURE
These statements have not been evaluated by the Food and Drug Administration (FDA). These products and statements are not intended to diagnose, treat, cure, or prevent any disease.

FORWARD-LOOKING DISCLAIMER
This press release may contain certain forward-looking statements and information, as defined within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and is subject to the Safe Harbor created by those sections. This material contains statements about expected future events and/or financial results that are forward-looking in nature and subject to risks and uncertainties. Such forward-looking statements by definition involve risks, uncertainties and other factors, which may cause the actual results, performance or achievements of Medical Marijuana, Inc. to be materially different from the statements made herein.

Corporate Contact:

Medical Marijuana, Inc.
Toll Free: 888-OTC-MJNA (888-682-6562)
www.medicalmarijuanainc.com
www.facebook.com/mjnainc

Investor Relations Contact:

Stuart T. Smith
SmallCapVoice.Com, Inc.
P. 512-267-2430
F. 512-267-2530
Email: ssmith@smallcapvoice.com
Skype: SmallCapVoice.com
AIM: SmallCapVoice7
SOURCE Medical Marijuana Inc.

 

SOURCE Medical Marijuana, Inc.
PR Newswire (http://s.tt/1oVH3)

COLORADO SPRINGS, Colo.–(BUSINESS WIRE)– Cannabis Science (CBIS), a pioneering U.S. Biotech Company developing pharmaceutical products for global public health challenges, reports on a recent press release by the San Francisco NBC news, with new studies by Scientists at California Pacific Medical Center, which have shown that cannabidiol, (CBD), has the ability to “turn off” a gene that causes breast and other types of cancers to metastasize, according to the San Francisco Chronicle newspaper.

NBC News reports, “The drug “has been shown to reduce pain and nausea” in cancer patients. AIDS patients also use cannabis to eat, sleep and otherwise be more functional. Turns out that cannabidiol has none of the psychotropic effects of marijuana as a whole. The researchers hope to move to clinical trials on humans soon to test the cannabidiol inhibition of metastasis, reported in the San Francisco Chronicle. “What they found is that the cannabinoid turns off the overexpression of ID-1, which makes the cells lose their ability to travel to distant tissues. In other words, it keeps the cells more local and blocks their ability to metastasize. (spread to a new location) The researchers stressed cannabidiol works only on cancer cells that have these high levels of ID-1 and these do not include all cancerous tumors but, rather, aggressive, metastatic cells. But they’ve found such high levels in leukemia, colorectal, pancreatic, lung, ovarian, brain and other cancers.”

Cannabis Science appreciates this additional scientific support that this report provides for our two target drug development programs as the Company moves forward with CS-TATI-1, and based on the success of previous skin cancer patients who self-administered cannabis-based treatments, the Company is focusing on the use of CS-S/BCC-1 topical cannabis-based preparations for the treatment of basal and squamous cell carcinomas.

Dr. Robert Melamede states, “Cannabis Science is excited for the increasing scientific support for our projects. In the near future, we will share new developments, as well a the progress we have made with our earlier defined initiatives. Our professional expansion and development, as detailed in our latest news releases,was driven by the science of how cannabinoids can benefit both HIV/AIDS and Cancer Patients.”

NBC News: http://www.msnbc.msn.com/id/49094732#.UFsvfY7nuZY

San Francisco Chronicle: http://www.sfgate.com/health/article/Pot-compound-seen-as-tool-against-cancer-3875562.php#page-1

About CS-S/BCC-1
Cannabis Science is currently working with CBR International to develop a Pre-IND Application to the FDA that focuses on the use of CS-S/BCC-1 topical cannabis-based preparations for the treatment of basal and squamous cell carcinomas. Cannabis Science has already seen success with 4 self-medicated skin cancer patients. These patients have been self-administering using cannabis-based extracts applied topically to their carcinomas and tumors. These patients have experienced shrinking and apparent eradication of their skin cancer, backed by positive reports from their doctors, which is why the Company is confident about the eminent success of this new drug to be developed.

About CS-TATI-1
Data published in March by researchers at the Mount Sinai School of Medicine found that cannabinoids inhibit TAT induced migration to TAT via cannabinoid 2 receptors (CB2). Funding for the Mount Sinai study was provided by a National Institutes of Health (NIH) Clinical and Translational Science Award Grant. Cannabis Science’s research of CS-TATI-1 will be targeted to newly diagnosed patients infected with drug resistant virus, treatment experienced patients with drug-resistant HIV strains, and those intolerant of currently available therapies. Cannabis Science will be pursuing a wide range of NIH based Federal Research Programs such as RO1’s, PO1’s and SBIRS which exist to support preclinical development of target validation and proof of concept studies. Cannabis Science will be pursing implementation of these studies through collaborations with leading scientific institutions. Cannabis Science will also be pursuing other clinical research collaborations including the AIDS Clinical Trials Groups (ACTG), the Canadian AIDS Trial Network (CATN) and the European AIDS Trial Network (EATN).

About Cannabis Science, Inc.
Cannabis Science, Inc. is conducting cannabinoid research and development for several critical ailments. The Company is currently developing two formulation drugs for critical ailments, Skin Cancer and HIV/AIDS. The Company works with leading experts in new drug development, medicinal characterization, and clinical research to develop, produce, and commercialize phytocannabinoid-based pharmaceutical products. Cannabis Science is currently working with CBR International to develop a Pre-IND Application to the FDA that focuses on the use of CS-S/BCC-1 topical cannabis-based preparations for the treatment of basal and squamous cell carcinomas. Preclinical development of CS-TATI-1 appears to inhibit HIV associated Kaposi Sarcoma by inhibiting HIV Tat. This cancer is significant threat to people with HIV. HIV Tat protein appears to trans activate Kaposi sarcoma. The inhibition of HIV Tat offers a promising new approach to inhibiting KSHV infective cycle.

Forward Looking Statements
This Press Release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Act of 1934. A statement containing works such as “anticipate,” “seek,” intend,” “believe,” “plan,” “estimate,” “expect,” “project,” “plan,” or similar phrases may be deemed “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Some or all of the events or results anticipated by these forward-looking statements may not occur. Factors that could cause or contribute to such differences include the future U.S. and global economies, the impact of competition, and the Company’s reliance on existing regulations regarding the use and development of cannabis-based drugs. Cannabis Science, Inc. does not undertake any duty nor does it intend to update the results of these forward-looking statements.

Contact:
Cannabis Science Inc.
Dr. Robert J. Melamede
President & CEO
1-888-889-0888
info@cannabisscience.com
www.cannabisscience.com
or
Robert Kane
VP Investor Relations
1-561-234-6929
rkane@cannabisscience.com
info@cannabisscience.com
www.cannabisscience.com

Findings inspire medical pot researcher

Wednesday, September 19, 2012 @ 10:09 PM  posted by theresa@idrasilrx.com
Victoria Colliver
Tuesday, September 18, 2012
  • Dr. Donald Abrams Photo: Dylan Entelis, The Chronicle / SF
    Dr. Donald Abrams Photo: Dylan Entelis, The Chronicle / SF

The therapeutic uses of cannabis have long been a focus of research for Dr. Donald Abrams, UCSF professor and chief of the hematology-oncology division at San Francisco General Hospital. Abrams wrote a study last year on the combination of cannabinoids – the main ingredient in cannabis or medical marijuana – and pain drugs. Abrams talks about the preclinical work by the California Pacific Medical Center Research Institute and other research on cancer and cannabis, 16 years after California became the first state to legalize medical marijuana.

Q: Is it difficult, due to stigma or the political climate, to do research on the therapeutic benefits of cannabis?

A: The only way you can get cannabis to do research in this county is through the National Institute on Drug Abuse, or NIDA, and it’s clear the congressional mandate is to study the substance for abuse rather than for treatment. It started in 1997 in HIV research when we studied whether it was safe to inhale cannabis while on protease inhibitors. The next study was through the UC Center for Medicinal Cannabis Research in 1999, when the state budget surplus allowed the state to devote $3 million for three years of studies to demonstrate whether cannabis had medical use. The funding enabled a number of studies and NIDA supplied the cannabis, but that money ran out.

If this plant were discovered in the Amazon today, scientists would be falling all over each other to be the first to bring it to market. But it has a stigma, and it’s being attacked by our government as part of the war on drugs.

Q: What kind of research are you doing now?

A: We did a study in patients with HIV who had damage to their nerves. We showed inhaling cannabis was better than inhaling a cannabis placebo for relieving those symptoms and that vaporization of cannabis was equivalent to smoking. The last study we did, which was again funded by NIDA, was looking to see if it was safe to combine cannabis with opiates – sustained-release morphine and sustained-release oxycodone. It was a small study … but we did note patients had increased relief of pain when cannabinoids were added to the opiates.

Q: What do you think of the research being done on triple-negative breast cancer cells at the California Pacific Medical Center Research Institute?

A: The data is promising and it’s elegant, but the true test is now really going to be to do some clinical trials in the patient population that (the researchers) think is correct to study at this time, which is patients with triple negative breast cancer. But at this time I would not tell my triple-negative patients to go out and look at taking high cannabidiol-containing cannabis products. We need to do the research. What happens in the test tube or even in animal models does not necessarily predict what happens in people. People are much more complex.

Q: What do you think about the University of Southern California study released last week that found a link between the recreational use of marijuana among young men and testicular cancer?

A: Young men use cannabis and get cancer. If they looked at video games and riding bicycles, that might also be associated. Is there an epidemic of testicular cancer in Jamaica where Rastafarians use cannabis religiously? I think that’s all a trick of numbers, personally.

Read more: http://www.sfgate.com/health/article/Findings-inspire-medical-pot-researcher-3875582.php#ixzz26xXIbS65

New Cannabis Pill Available in California

Wednesday, September 19, 2012 @ 10:09 PM  posted by theresa@idrasilrx.com

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