Jon Gettman is a long time contributor to HIGH TIMES. A former National Director of NORML, Jon has a Ph.D. in public policy and regional economic development and consults with attorneys, advocates, and non-profits on cannabis related research and public policy issues. On October 8, 2002, along with a coalition of organizations, he filed a new petition to have cannabis rescheduled under federal law. This column will track that petition's progress.
Sativex and Medical Cannabis
Rhode Island became the 11th state to enact medical marijuana legislation on January 3rd, and on January 4th the Food and Drug Administration (FDA) approved a proposal to expedite clinical testing of Sativex, a promising pharmaceutical product that is made from natural cannabis extracts.
The Rhode Island legislation refers to “marijuana” because its primary purpose is to protect medical usage of cannabis from arrest and prosecution under the state’s more general laws concerning the use, possession, and sale of cannabis sativa. The state limits the definition of a debilitating condition to cancer, glaucoma, HIV status, AIDS, or hepatitis C and requires qualifying patients to register with a state agency and receive an ID card. Qualified caregivers are allowed to assist 5 patients procure marijuana, and they may be reimbursed for their costs. Rhode Island will consider expanding the list of conditions approved for medical marijuana use. All in all it’s a good start toward protecting patients from arrest and providing them with a legal means to acquire the drug. Patients and caregivers, for example, are allowed to grow modest quantities of marijuana for medical use.
GW Pharmaceuticals has been working for years on bringing their cannabis-derived drug Sativex to market. Sativex is not medical cannabis, but it is the closest thing the pharmaceutical industry has been able to come up with to provide patients a legal product available through conventional medical channels. These channels are highly regulated, making the drug development process very expensive and, more importantly, a very lengthy process. The length of this process creates a gap between the time patients know about the potential benefits of the ingredients of cannabis and the time the can have access to legal, regulated products.
The passage of medical cannabis legislation, regardless of the terms involved, in 11 states is a result of this gap phenomenon. Legislators are sympathetic to the plight of patients with debilitating conditions, especially when there is no alternative to marijuana use. In many ways medical cannabis legislation has been viewed as ‘emergency legislation’ that provides minimal protection to patients who use marijuana to relieve the symptoms of debilitating medical conditions.
What will happen to medical cannabis legislation once a pharmaceutical alternative is available? The steady emergence of Sativex suggests that date is, finally, relatively near – recent FDA action indicates that GW’s cannabis extract product could be available to US patients within 5 years.
On January 4th the FDA accepted an Investigational New Drug (IND) application that allows GW Pharmaceuticals to directly into phase III clinical trials. These final tests will take 24 to 36 months, after which GW will be able to apply for regulatory approval to market Sativex in the United States.
Sativex is a composite of natural cannabis extracts. GW Pharmaceuticals combines extracts with known amounts of tetrahydrocannabinol (THC) and cannabidiol (CBD), the primary therapeutic ingredients of cannabis, and delivers them to patients in the form of an oral spray directed under the tongue. Sativex has been extensively tested in successful clinical trials in Europe and in April 2005 was approved in Canada for the symptomatic relief of neuropathic pain in multiple sclerosis
The US clinical trials will evaluate the drugs effectiveness in the treatment of pain in advanced cancer patients who have not received adequate pain relief from opioid medications. GW has previously completed a phase III study in Europe with 177 patients with pain-related cancer. One of the US phase III studies will include 250 patients.
The FDA approval follows a meeting with GW in June 2005 to discuss the results of prior clinical trials in Europe, and includes written guidance for the US studies that will expedite regulatory approval if the trials are successful.
Regulatory approval of pharmaceutical drugs is a lengthy process, even under the best of circumstances. Phase I studies determine safety and proper dose. Phase II studies evaluate the effectiveness of a drug and look for side-effects. Phase II studies confirm effectiveness in a larger sample than phase II studies, and also look for adverse reactions from long term use. An IND is required to conduct clinical trials in the US, and the results of these clinical trials are required to submit a New Drug Application (NDA) seeking marketing approval. The three phases of clinical trials usually takes five years while approval of the final NDA takes about 15 months.
On this timeline FDA could approve an NDA for Sativex as early as 2009. Then the final hurdle in getting Sativex to market would be scheduling under the Controlled Substances Act. Given that GW has been clever enough to expedite the required US clinical studies it’s a good bet they’ll figure out a way to expedite the scheduling process for Sativex as well. For these and other reasons it’s a good bet that Sativex will be available in the US in 2010 or shortly thereafter.
The availability of Sativex in the United States will be a great development for patients afflicted by a number of ailments. After its introduction research will increase and additional uses will approved by the FDA. If Sativex is effective and accepted by a large number of doctors and patients it will expedite research, development, and approval of other cannabis-based pharmaceuticals.
Sativex is part of a larger technological revolution, the shift from smoking to vaporization. Most of the health risks associated with marijuana use are produced by smoking. Vaporization turns the active ingredients in cannabis to inhalable vapor without igniting the plant material. In other words, no smoke, and no risk from exposing the mouth, throat, and lungs to smoke. This technological development further sharpens the distinction between illicit smoked marijuana of the 20th century and emerging acceptance of vaporized cannabis in the 21st century. Removing the harm of marijuana smoke from the equation will ease this transition and the potential legal and policy impact it has.
Medical cannabis is different from the pharmaceutical products created from or created to resemble its natural ingredients. It is different from Marinol (synthetic THC) and it is different from Sativex (a composite for naturally derived THC and CBD). Medical cannabis is a different source for these and other active ingredients, and it has other characteristics that distinguish it from pharmaceutical products. Nonetheless, the real difference, and the only important difference, is the one recognized by the patient and their physician. The crucial issue is getting the medical cannabis user recognized as a patient capable of making informed decisions about their treatment.
The popular conception of legal medical cannabis, though, is a licensed cultivation and distribution system for medical use operating under state and/or federal law. The problem with this is that it involves complex policy issues above and beyond the matter of medical cannabis, it involves a larger issue of alternative versus traditional medicine. It may well be a mistake to conceive of medical cannabis laws in terms of traditional medicine rather than thinking of them as protections for patients who choose alternative medicine based on both necessity and informed consent.
Medical cannabis legislation will not become obsolete with the emergence of Sativex because it benefits individual patients, their families and friends, and contributes to the public interest. The demands of space and time are asserting themselves on the movement. The demands of space are the needs of patients in the rest of the United States who require protection from arrest for medical cannabis use while the demands of time are, obviously, made clear by the number of patients who can’t wait for legal Sativex five years from now.
Jon Gettman writes the monthly “Cannabis Column.” He’s a contributor to HIGH TIMES and hightimes.com, and is the former executive director of NORML.