Archive for the ‘Marinol’ Category

Researchers at McGill University Health Centre, the McGill University in Montreal and the University of British Columbia in Vancouver, Canada, said that as the use of cannabinoid medications increases, so do concerns about their potential to cause “adverse events.” Dr. Mark Ware of the McGill University Health Centre said that their analysis reported about 31 separate clinical studies of cannabinoid medications conducted between 1966 and 2007. Adverse events were categorized as either serious or non-serious; with serious adverse events defined as those leading to death, hospitalization or disability.

“Overall, we found an 86 percent increase in the rate of non-serious adverse events among the patients treated with cannabinoids compared to the patients in the control groups,” Ware said in a statement. “The majority of events were mild to moderate in severity.” The majority of non-serious adverse events observed involved dizziness and drowsiness, the researchers said. The findings were published in the Canadian Medical Association Journal and are available online including a comment by Australian researchers.

More at:
www.cmaj.ca/cgi/content/full/cmaj;178/13/1669
www.cmaj.ca/cgi/content/full/178/13/1685

(Sources: UPI of 17 June 2008; Wang T, Collet JP, Shapiro S, Ware MA. Adverse effects of medical cannabinoids: a systematic review. CMAJ 2008;178(13):1669-78; Degenhardt L, Hall WD. The adverse effects of cannabinoids: implications for use of medical marijuana. CMAJ 2008;178(13):1685-6.)

Science/USA: Controversies on the consequences of the increase of cannabis potency in recent decades

According to a report released by the American White House the average THC (dronabinol) concentration of cannabis seized in the United States increased from about 4 per cent in 1983 to 9.6 per cent in 2007. “Marijuana potency has grown steeply over the past decade, with serious implications in particular for young people,” John Walters, director of the White House Office of National Drug Control Policy, said. He cited the risk of psychological, cognitive and respiratory problems, and the potential for users to become dependent on drugs such as cocaine and heroin.

However, an increase of cannabis potency within the past 25 years of about two and a half refute claims of a dramatic increase in recent decades and confirm results by Australian researchers, who investigated the development of dronabinol concentrations of cannabis in several countries. The researchers at the Australian National Drug and Alcohol Research Center and the National Drug Research Institute also noted that the claims that increased strength of cannabis is driving the occurrence of mental health problems is not supported by studies. Due to the enormous variation between samples cannabis users may be exposed to a greater variation in the strength of the cannabis they use in a single year than that over years or decades.

More at
hosted.ap.org/dynamic/stories/M/MARIJUANA_POTENCY?SITE=FLTAM&SECTION=HOME&TEMPLATE=news_generic.htm
www.upi.com/Health_News/2008/06/18/Pot_potency_may_have_mitigating_factors/UPI-18501213813100/

(Sources: Associated Press of 12 June 2008, UPI of 18 June 2008; McLaren J, Swift W, Dillon P, Allsop S. Cannabis potency and contamination: a review of the literature. Addiction 2008;103(7):1100-9.)

News in brief

USA: Cannabis use by teens
According to an analysis by researchers of the State University of New York state medical cannabis laws in twelve states have not increased teen cannabis use, despite fears that have been raised when such measures are considered. Teen cannabis use has consistently declined in states with medical cannabis laws, and generally more markedly than national averages. The report, based entirely on data from federal and state government-funded drug use surveys, is available at www.mpp.org/teens/. (Source: MPP of 16 June 2008)

USA: Deaths from medical drugs
An analysis of autopsies in 2007 from Florida found that the rate of deaths caused by prescription drugs was three times the rate of deaths caused by all illegalized drugs combined. According to a report by the New York Times these findings track with similar studies by the federal Drug Enforcement Administration, which has found that roughly seven million citizens of the United States are abusing prescription drugs. If accurate, that would be an increase of 80 per cent in six years and more than all citizens abusing cocaine, heroin, hallucinogens, Ecstasy or inhalants. (Source: New York Times of 14 June 2008)

Science: Cannabidiol
According to research from Japan cannabidiolic acid, the form in which cannabidiol (CBD) is present in the cannabis plant, is a selective cyclooxygenase-2 inhibitor (COX-2 inhibitor). Delta-9-tetrahydrocannabinolic acid (THCA) was much less potent. COX-2 inhibitors have an anti-inflammatory effect. Drugs such as aspirin (acetysalicylic acid) suppress the production of prostaglandins and thromboxanes due to its inactivation of the cyclooxygenase (COX) enzyme. However, besides COX-2 aspirin inhibits also COX-1 enzymes, which may result in side effects such as stomach bleeding. (Source: Takeda S, et al. Drug Metab Dispos, 2008 Jun 12. [Electronic publication ahead of print])

Science: Granulomas
According to research by Italian scientists cannabinoids, which activate the CB1 or the CB2 receptor inhibit the production of blood vessels in granulomas and thus reduce inflammation in conditions associated with granulomas. They are seen in diseases such as Crohn’s disease, tuberculosis and sarcoidosis. (Source: De Filippis D, et al. Br J Pharmacol, 2008 Jun 16. [Electronic publication ahead of print])

Science: Lymphomas
According to researchers of the Karolinska Institute in Stockholm, Sweden, high CB1 and CB2 receptors levels are found in most non-Hodgkin lymphomas. Cannabinoids induced cell death in these cancer cells. Researchers concluded, that “our results suggest that therapies using cannabinoid receptor ligands will have efficiency in reducing tumor burden in malignant lymphoma overexpressing CB1 and CB2.” (Source: Gustafsson K, et al. Int J Cancer, 2008 Jun 10. [Electronic publication ahead of print])

This article reviews recent research on cannabinoid analgesia via the endocannabinoid system and non-receptor mechanisms, as well as randomized clinical trials employing cannabinoids in pain treatment. Tetrahydrocannabinol (THC, Marinol^®) and nabilone (Cesamet^®) are currently approved in the United States and other countries, but not for pain indications. Other synthetic cannabinoids, such as ajulemic acid, are in development. Crude herbal cannabis remains illegal in most jurisdictions but is also under investigation. Sativex^®, a cannabis derived oromucosal spray containing equal proportions of THC (partial CB₁ receptor agonist ) and cannabidiol (CBD, a non-euphoriant, anti-inflammatory analgesic with CB₁ receptor antagonist and endocannabinoid modulating effects) was approved in Canada in 2005 for treatment of central neuropathic pain in multiple sclerosis, and in 2007 for intractable cancer pain. Numerous randomized clinical trials have demonstrated safety and efficacy for Sativex in central and peripheral neuropathic pain, rheumatoid arthritis and cancer pain. An Investigational New Drug application to conduct advanced clinical trials for cancer pain was approved by the US FDA in January 2006. Cannabinoid analgesics have generally been well tolerated in clinical trials with acceptable adverse event profiles. Their adjunctive addition to the pharmacological armamentarium for treatment of pain shows great promise.

They don’t just mean in California. A pill known as Marinol has been legal and approved by the Food and Drug Administration for use with a prescription anywhere in America since 1985.

It’s active ingredient? Dronabinol, better known as THC, the primary psychoactive element of the cannabis plant.

“Marinol provides standardized THC concentrations, does not contain the other 400 uncharacterized substances found in smoked marijuana, such as carcinogens or fungal spores, and is not associated with the quick high of smoked marijuana,” said Neil Hirsch, a spokesman for Marinol manufacturer Solvay Pharmaceuticals.

But Marinol is not the same thing as traditional, smokable marijuana. It is a less complex substance lacking both some of the good components found in traditional marijuana (such as cannabidiol, which has been found to have anti-seizure effects) and the bad or not-yet-fully-understood components (among them potential carcinogens) that can also come with the drug.

Ken Trainer, a 60-year-old Massachusetts resident who has battled Multiple Sclerosis for 25 years, said he has long been smoking marijuana to deal with the regular tremors he gets in his arms and legs.

“If I smoke a joint, the tremors go away most times before the joint is gone,” he said. “It makes my life a little easier.” Marinol, by contrast, “didn’t really do much of anything for me,” he said.

56-year-old Des Moines resident Jeff Elton, who was diagnosed with gastroparesis six years ago, had a similar experience when he was prescribed Marinol to deal with his chronic nausea and vomiting.

“I felt no relief, I didn’t feel ill, I felt nothing,” he said. “It might as well be M&M’s.”

Elton said he switched to marijuana, which he smokes through a vaporizer – a device that heats the active ingredients into a vapor instead of burning them. He said it allows him to keep down his food and regain some of the weight he lost while on Marinol.

“[One] problem with Marinol is that it’s orally administered,” Dr. Mitch Earleywine, an associate professor of Clinical Psychology at the State University of New York at Albany, said in an email. “Therefore, it takes longer to work than cannabis inhaled from a vaporizer. (Usually 90 minutes at best rather than 15 seconds – a meaningful amount of time to the nauseated.)”

“It’s harder to control dosage, too, so folks end up discombobulated or without symptom relief,” he added. “In addition, folks who are vomiting can’t hold down the pills.” Earleywine also said that a dose Marinol costs three to five times as much as a comparable dose of medical marijuana.

Defenders note that Marinol is not meant to be a cure-all: It has been approved specifically for treating nausea and vomiting associated with cancer chemotherapy and for treating anorexia associated with weight loss in patients with AIDS.

“When the whole push for the smoked product came along, it was often for those two indications,” said Dr. Herbert Kleber, a professor of Psychiatry at Columbia University and the former deputy drug czar under President George H.W. Bush. “And in general, I’ve not seen any need for the smoked form of marijuana for those two indications. Marinol had already been shown to be quite effective for those two things.”

“Are there actions in the whole plant that you don’t get from just the Marinol? I would be surprised if there wasn’t,” he continued. “The problem is that most of the data about the potential medical actions of the smoked form are anecdotal.”

Research into the effects of medical marijuana is ongoing: The University of California, San Diego, for example, boasts a Center for Medicinal Cannabis Research engaged in “focused controlled clinical trials on the efficacy of cannabis in patients diagnosed with HIV/AIDS, cancer, seizures or muscle spasms associated with a chronic debilitating condition, or any other serious condition providing sufficient theoretical justification.” (The director of the UCSD program, Dr. Igor Grant, was out of the country and could not be reached for this story.)

The Los Angeles Times, which offers a nice overview of the current research, writes that “a growing body of research supports [medical marijuana's] medical usage, but some of it is cautionary.” Marijuana has been found to be effective in counteracting severe pain, nausea and loss of appetite, though questions remain about the drawbacks, among them possible respiratory damage and increased cancer risk.

Dr. Kleber, who said he has prescribed Marinol to a patient and found it to be effective, points to what he characterizes as a significant advantage of the pill over traditional marijuana: “People don’t abuse it.”

“Marijuana addiction is becoming common and as a result I’m seeing an increasing number of people who have trouble stopping marijuana,” he said. “Contrary to popular beliefs that there is no marijuana withdrawal, there is marijuana withdrawal. It’s very clear cut.”

The calculus, then, isn’t quite as simple as the Drug Enforcement Administration suggests: Marinol and medical marijuana may share an active ingredient, but they offer somewhat different benefits and different drawbacks. Proponents of medicinal marijuana say it’s disingenuous to hold up Marinol as a direct alternative to the more traditional form of the plant.

“I just don’t understand how they won’t let me smoke a joint, but they’re more than happy to write me out prescriptions for anything that I want,” Trainer said.

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