Sativex: change of thinking?

Prototype inhaler from G.W. PharmaceuticalsPrototype inhaler from G.W. PharmaceuticalsAs news reports echo that Canada is the first country in the world to license a plant-based cannabinoid pharmaceutical medicine in the modern era, the future of cannabis law in the US is being affected by the implications of the Canadian decision.
Sativex, created by GW Pharmaceuticals and marketed in conjunction with Bayer, is a combination of plant-derived delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD).

It’s administered via a spray pump which places Sativex spray under the tongue or on the inside of the cheek. Unpleasant effects are said to be extremely rare, and the mode of administration assists in micromanaging patient needs.

Government reports based on medical studies indicate that Sativex offers pain relief and other medical benefits with a very low possibility of negative side effects. The reports and Sativex approval helped GW in the stock market, and the company announced that it wants to spend more money convincing US government regulators that cannabis studies should be conducted there too. Presently, US medical cannabis studies are blocked by various federal agencies, and researchers complain that this is preventing balanced debate about cannabis law and medical cannabis policy.

Medical law observers consider Canada’s Sativex approval a possible symbol of what could be a major philosophical shift regarding cannabis amongst the medical products regulatory community. The drug is awaiting approval in its home country of the UK, where it was developed by GW Pharmaceuticals after the company grew thousands of pot plants.

The company grew literally hundreds of thousands of specially-bred organic marijuana plants to create plant extracts and carry on clinical cannabis trials, and is the first to convince modern regulators that a formula based on live cannabis plants is effective, reliable and safe.

The Canadian approval of Sativex is significant because it was marijuana plants themselves, not a chemical factory that produced the THC and CBD in Sativex. In almost all instances, drugs based on primarily natural non-chemical plant derivates fail to get regulatory approval because regulators have an arbitrary source material standard that inherently excludes natural extracts. The pharmaceutical industry and its lackeys in regulatory agencies prefer machine-made drugs. The philosophical underpinnings of modern drug medicine protocols assume that natural substances are inferior, unpredictable and unsafe.

In the Sativex case, however, nature’s pharmacopeia was well-respected, for even though human manipulation is inherent to the Sativex manufacturing process, the medicine’s key cannabinoidic healing components are natural, and are firmly based on two cannabinoids that represent the majority of cannabinoids transmitted into people when they smoke marijuana.

Sativex is of course different than using combustion to deliver THC and CBD, but the main cannabinoids delivered by Sativex are also the main cannabinoids delivered by inhaling marijuana smoke. It’s almost as if Sativex is a non-smoked, “natural medicine.”

Dr. Geoffery GuyDr. Geoffery GuySativex as evidence

The medical value of plant-derived cannabinoids, seen in the balanced THC/CBD profile of Sativex as only one of many possible natural cannabinoid medicines, is being researched for a variety of applications around the globe. There are already numerous patents or intellectual property rights for cannabinoids in various forms.

That’s why a coalition of grassroots medical cannabis patients and advocacy organizations have used medical cannabinoid value and efficacy as a major premise of their landmark cannabis petition that is winding its way through the halls of the US federal government.

The petition, sponsored by the Coalition to Reschedule Cannabis, asks the US government to change its regulatory policies toward marijuana. The petition demands that the government give a fair hearing to new research and regulatory approval of cannabis or cannabis medicines in other countries, such as when Sativex received approval in Canada.

This approach is not a new idea: last year, when the Raich/Monson medical marijuana case was being argued in front of the Supreme Court, a Justice suggested the legal status of marijuana could best be handled by changing its category in the “Schedule List” of the Controlled Substances Act.

The Coalition to Reschedule Cannabis consists of individuals and organizations who want US medical regulators to recognize the medical benefits of cannabis, and to change the way the government classifies cannabis. Cannabis is right now considered “Schedule One,” which means that the government decided- not just as a matter of law but as a matter of medical/social policy- that marijuana is a drug with no medical value and a high potential for abuse.

The US government placed cannabis as Schedule One, knowing that this categorization of cannabis has the most negative connotations attached to it. The government asserts that it has definite proof that marijuana totally lacks medical value and has a high potential for abuse. If a drug has medical value, it is not supposed to be on Schedule One.

Independent medical specialists and institutions such as the Canadian government now say plant extracts from cannabis are well-suited to uniquely treat the variable nature of neuropathic pain such as that experienced by people with Multiple Sclerosis (MS), which is the main target patient audience for GW’s Sativex. Sativex is also found to have other healing properties, such as its ability to safely induce restful sleep. Cannabinoid medicines are useful for a variety of health problems, and are safer than the chemical pharmaceuticals they compete with.

How could Sativex cannabis extract, a controlled dose of natural cannabinoids extracted from plants, have unique, safe medical value in the eyes of the government, but the whole plant has no medical value? This contradiction is one reason Sativex approval in Canada is seen as another piece of evidence to support the Coalition’s claim that US medical regulators are ignoring science and due process by continuing to claim that marijuana is not medicine, and by continuing to have cannabis labeled as a dangerous Schedule One drug.

Dr. Geoffery GuyReconsider

Some observers in the US fear that the Supreme Court will rule against Raich/Monson (and by doing so also rule against state-based medical marijuana laws). If the Court thus rules, its rationale is expected to be that medical marijuana is a medical issue that should be adjudicated by medical regulators, not by courts, not even by Congress.

The Coalition has already started the medical review process. In 2002, it launched its extensive legal and scientific challenge to the Drug Enforcement Administration’s (DEA) “prohibition via Scheduling” of cannabis in the United States.

The challenge was based on contradictions inherent in DEA policy, and on DEA’s mistaken assertions about cannabis that have been superseded by facts. This is the second go-round for the petition, which was turned down before, when courts ruled that the petitioners had no valid standing to request rescheduling.

The current petition is not expected to be dismissed on such technicalities, and includes medical testimony and other solid documentation to show that the DEA is wrong when it asserts cannabis has no medical value. The Coalition presents evidence challenging DEA claims that cannabis has a high potential for abuse- similar to that of cocaine and heroin.

Coalition spokespersons say the DEA has never provided comprehensive scientific evidence to support its Schedule One designation for marijuana, nor does US law give the DEA exclusive power to dictate the meaning of scientific research and assign drugs to specific schedules. The laws of the United States do not give the DEA this much authority, the Coalition asserts. In fact, the laws of the United States obligate the DEA to pay most attention to legitimate scientific record, and the laws further obligate the DEA to expedite medical access to cannabis patients in need.

Coalition member Al Byrne, who co-founded the medical cannabis educational organization Patients Out of Time (POT), says that the rescheduling petition obligates DEA and the US federal Department of Health and Human Services (HHS) to do a full medical and scientific evaluation of medical cannabis.

POT is the type of professional cannabis organization interested in the detailed nuts and bolts of cannabis policy as it pertains to medical issues. Byrne’s wife, Mary Lynn Mathre, is an influential nurse and medical expert who has helped Byrne and POT organize the only clinical cannabis conferences so far held in the US, with one planned for 2006 in Santa Barbara. Mathre and Byrne have also been influential in educating major US nursing organizations so that the organizations have publicly come out in support of cannabis medicine.

Byrne says that the rescheduling process so far is slow but useful, and that the DEA has reviewed Coalition petition paperwork, decided that the petition has merit, and last year referred the petition to Health and Human Services.

HHS has until 2007 to issue a medpot report and rule on whether cannabis can be placed in Schedule Two or below. The Coalition’s demand to reschedule could end up as a legal case if the HHS ruling is not medically accurate.

To hasten consideration of the petition, Byrne says, the Coalition is contacting every member of the US Congress, outlining the petition and asking Congresspersons’ help in finding out if HHS can honor pro-cannabis medical science, and heed the message of Canadian approval of Sativex, as reasons to finally put cannabis on Schedule Two or below.

This rescheduling would loosen or remove cannabis penalties, allowing more medical use, cultivation and research, and demonstrating a rational approach to public policy. The Coalition is counting on key congresspersons, including influential senators, to help the Coalition find out if HHS is taking seriously the consideration of all available evidence regarding cannabis as medicine by expediting the request to reschedule marijuana.

Observers note that approval of Sativex lends more credence to the idea that cannabis is a valid medicine. If plant-based cannabinoids are medicine, this supports the argument that marijuana itself does not belong in Schedule One status, where all drugs are presumed to be without medical value.

The only other thing the government could argue, if it admits that cannabis has medical value, is that cannabis has high potential for abuse. This assertion is contradicted by evidence; only a small percentage of people who try cannabis become dependent on it, and the harms of using cannabis are small compared to the harms of using prescription drugs, alcohol, tobacco and caffeine. Even if cannabis was a drug with a high potential for abuse, this alone cannot justify keeping an effective medicine in Schedule One. Many over the counter drugs and pharmaceutical drugs would be in Schedule One if they were as negatively and rigorously evaluated as marijuana.

And if US government still argues that cannabis is not a medicine, its experts should to look to northern neighbor Canada to see essentially the same substance, delivered in a spray form, already helping patients.

“This is a hard one for the government,” Byrne says, “but really it’s easy for them if they follow the science, because the facts are totally on the side of rescheduling, and they would be applauded from all sides for honoring the science. Cannabis clearly has tremendous medical usefulness, as Sativex has shown, so cannabis as medicine will continue to help thousands of patients worldwide in a variety of ways that will only become more numerous as research progresses. We hope to soon hear that HHS has approved the request, so that the day of Schedule One for cannabis is finally over.”Dr. Geoffery Guy

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