Tetrahydrocannabinol (THC - medical marijuana)

Tetrahydrocannabinol (THC - medical marijuana)

Yet another heavily FDA suppressed treatment. "The term medical marijuana took on dramatic new meaning last February, when researchers in Madrid announced they had destroyed incurable brain cancer tumors in rats by injecting them with THC, the active ingredient in cannabis. Most Americans don't know anything about the Madrid discovery. Virtually no U.S. newspapers carried the story, which ran only once on the AP and UPI news wires, on Feb. 29. The ominous part: This isn't the first time scientists have discovered that THC shrinks tumors. In 1974, researchers at the Medical College of Virginia had been funded by the National Institutes of Health to find evidence that marijuana damages the immune system. Instead, they found that THC slowed the growth of three kinds of cancer in mice -- lung and breast cancer and a virus-induced leukemia. The government quickly shut down the Virginia study and all further cannabis/tumor research, according to Jack Herer, who reports on the events in his book, The Emperor Wears No Clothes. In 1976, President Gerald Ford put an end to all public cannabis research and granted exclusive research rights to major pharmaceutical companies, which set out -- unsuccessfully -- to develop synthetic forms of THC that would deliver all the medical benefits without the "high."
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Sativex(r) Cannabis Oral Spray Accepted in Canada and Approved for US Clinical Trials

HerbalGram. 2006;70:22-23 (c) American Botanical Council (Buy This Issue)
The cannabis-based medicine Sativex(r) is gradually gaining recognition within the international health community. Sativex was made available within Canada in June 20051 and approved for testing in US clinical trials in January 2006.2 Sativex, an oro-mucosal spray derived from marijuana (Cannabis sativa L., Cannabaceae), is intended for the relief of severe pain associated with such conditions as multiple sclerosis (MS) and cancer. It is a whole cannabis extract from two chemovars of cannabis-one primarily expressing tetrahydrocannabinol (THC) and the other expressing cannabidiol-that contains the plant's full range of natural phytocannabinoids and terpenoids (E. Russo, e-mail, January 31, 2006).
Canada became the first country in the world to approve Sativex as a prescription medication in April 2005 as an adjunctive treatment for symptomatic relief of neurological pain in adults with MS.[ 1] It was approved under Health Canada's Notice of Compliance with Condition status, requiring that the UK-based company GW Pharmaceuticals, the manufacturers of Sativex, pursue further clinical trials regarding efficacy. Sativex is marketed in Canada by Bayer HealthCare.

The US Food and Drug Administration (FDA), meanwhile, accepted GW's Investigational New Drug (IND) Application for Sativex, allowing GW to launch Phase III clinical trials in the United States.[ 2] These trials will test the drug's ability to treat pain in advanced cancer patients who have not found relief through conventional opioid medications (e.g., codeine, morphine, and/or their synthetic analogs). GW has planned 2 extensive clinical trials and some smaller-scale supporting studies for its US clinical program, which is likely to commence in late 2006. "Proceeding with cancer pain indication seemed to offer the optimal route for opening discussions with the FDA," said Mark Rogerson, GW's head of press and PR (e-mail, January 9, 2006). "GW does not anticipate stopping at cancer pain in the US, but rather will seek to investigate Sativex in other medical indications in due course." GW expects to file a regulatory submission with the FDA 2 to 3 years after the trials commence.

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Clinical trials of Sativex in the United States-particularly if successful-could help open the door to further FDA-approved US cannabis research, said Dennis McKenna, PhD, senior lecturer and research associate at the University of Minnesota's Center for Spirituality and Healing and Adjunct Professor of Clinical and Experimental Pharmacology (oral communication, January 2006). Furthermore, the approval of an IND Application for Sativex may indicate a significant shift within the FDA itself, which has proven a highly politicized agency in the past regarding controversial issues. "This may signify that the FDA is changing its stance and basing its decisions on good scientific judgment and medical judgment, as opposed to political motivations," Dr. McKenna said.

GW was able to successfully introduce Sativex into Canada and begin the regulatory review process in the United States, due to the positive results garnered from previous clinical trials. Sativex proved significantly effective at reducing MS pain in a study published in the journal Neurology[ 3] in 2005 (reviewed in >HerbalGram 69[ 4]). Further studies with MS patients have also indicated that Sativex alleviates other MS symptoms, including spasticity, spasms, bladder symptoms, and sleep disturbance.[ 5] Likewise, clinical trials of Sativex have demonstrated the drug's efficacy in treating intractable cancer pain, rheumatoid arthritis pain,[ 6] peripheral neuropathic pain with allodynia (severe pain from stimuli that are normally painless, caused by damage to the central nervous system), and brachial plexus injury pain (pain caused from damage of the nerves that conduct signals from the spine to the shoulder, arm, and hand).[ 5]
"The clinical benefits noted with Sativex have been maintained in long-term safety extension studies (some up to four years)," said Ethan Russo, MD, senior medical advisor of the Cannabinoid Research Institute of GW. "During that interval, no tolerance has developed to these therapeutic benefits, no significant withdrawal symptoms have been noted on abrupt withdrawal of Sativex, and in regular usage, patient subjective intoxication scores on the medicine have been indistinguishable from placebo. All of these benefits of Sativex have occurred in patient groups who qualified for clinical trials with this new medicine after failure of available conventional treatment. The changes in their conditions were thus above and beyond those attainable with other [conventional] pharmaceuticals."

According to Rogerson, GW purposefully allowed itself time to generate extensive data on Sativex in Europe before embarking upon discussions with FDA. "This strategy has now provided the optimum outcome in allowing us to proceed directly into US Phase III trials, thus compressing the overall potential timelines to filing a regulatory submission. We are delighted that the FDA has accepted this approach," Rogerson said.

Physicians and patients in Canada, meanwhile, have expressed excitement about achieving first use of the drug. Allan Gordon, MD, a neurologist and the director of the Wasser Pain Management Centre and the Edward Bronfman Family Foundation MS Research Clinic at Mount Sinai Hospital in Toronto, Ontario, began prescribing Sativex to some of his patients in the Spring of 2005 (A. Gordon, oral communication, November 2005). According to Dr. Gordon, many physicians in Canada have welcomed Sativex as a new treatment option for pain management. He added that MS patients, moreover, typically express approval of the medication's spray format, which gives them some degree of control over their treatment.

Many conventional pharmaceutical treatments for MS pain include anti-depressants, anti-epileptic medications, and opiates. "If it's truly nerve pain, however, you need some sort of treatment more specific to nerve pain," Dr. Gordon explained. Sativex, therefore, is particularly appealing, due to its clinically proven efficacy in treating nerve pain and spasms. Although it currently is used as an adjunctive treatment with other pain medications, Dr. Gordon said it may eventually serve as a primary pain medication for patients with MS. "Right now, we're just trying to learn how to use it," he said. "Cannabinoids represent a brave new world of therapy. They have not yet been investigated thoroughly and are very promising. I think 10 years from now we'll have a lot more information."

Pain is a common symptom of both MS and advanced cancer. Central pain, which is caused by a primary lesion or dysfunction of the central nervous system, is estimated to occur within 17 to 52% of people with MS; around 32% of patients classify it among their worst symptoms.[ 3] Cancer pain, meanwhile, can be caused by tumors or by cancer treatments, such as radiation or chemotherapy.[ 7] Studies indicate that 30 to 50% of patients who undergo active treatment for cancer and 70% of those with advanced stages of the disease experience significant pain.
GW's goal is to ultimately obtain marketing approvals for Sativex throughout the world (M. Rogerson, e-mail, January 9, 2006). In addition to its presence within Canada and its preliminary introduction into the US FDA, Sativex is currently available to individual patients as an unlicensed medication in the UK and to certain patients in Spain under a compassionate access program.

References

1. Sativex-novel cannabis derived treatment for MS pain now available in Canada by prescription [press release]. Toronto, Ontario: Bayer HealthCare; June 20, 2005.

2. Sativex to enter directly into phase III cancer pain trials in United States [press release]. London: GW Pharmaceuticals; January 4, 2006.

3. Rog DJ, Nurmikko TJ, Friede T, and Young CA. Randomized, controlled trial of cannabis-based medicine in central pain in multiple sclerosis. Neurology. 2005;65:812-819.
4. Blumenthal M. Sativex cannabis-based medicine reduces pain in MS patients. HerbalGram. 2006; No. 69:34-35.
5. Russo EB, Guy GW. A tale of two cannabinoids: the therapeutic rationale for combining tetrahydrocannabinol and cannabidiol. Medical Hypotheses. 2006;66 (2):234-246.

6. Blake DR, Robson P, Ho M, Jubb RW, and McCabe CS. Preliminary assessment of the efficacy, tolerability and safety of a cannabis-based medicine (Sativex) in the treatment of pain caused by rheumatoid arthritis. Rheumatology. 2006;45(1):50-52.

7. Spotlight: Communicating about Cancer Pain. National Cancer Institute Web site. Available at: http://www.cancer.gov/ncicancerbulletin/NCI%5fCancer%5fBulletin%5f 112905/page4. Accessed January 17, 2006.
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By Courtney Cavaliere

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