Defending its crack-down on legal medical marijuana dealers, the DEA has disingenuously declared that pot is an ineffective treatment for pain. But over at the FDA, the first painkiller made from cannabis is sailing toward approval.
By Dirk Hanson
It’s hard to deny claims by critics that the president has largely given the shaft to advocates of medical marijuana. Hitting the re-election trail this week, Obama had to duck a question about his record on pot-for-pain at a Minnesota town hall meeting, leaving unresolved–after more than two and a half years–his campaign promise to respect the right of patients to make decisions about their own care. Instead his administration has pursued a confused two-pronged policy: allowing Big Pharma unimpeded license to pursue the profitable medical marijuana market, while threatening thousands of patients using state-licensed cannabis with federal intervention and even arrest.
Critics liken Obama’s cannabis conundrum to the way he dealt with the financial crisis–bailing out Wall Street while leaving millions of homes on Main Street to fall into foreclosure. If this sounds like too harsh a condemnation of a president that rabid Republicans have done nothing but hate on, try making sense of recent developments in federal medical-marijuana policy.
Back in March, the U.S. Drug Enforcement Administration (DEA) exercised its emergency authority to outlaw the use of five “fake” marijuana products like Spice and K2. “These products consist of plant materials that have been coated with research chemicals that claim to mimic THC, the active ingredient in marijuana, and are sold at a variety of retail outlets, in head shops and over the Internet,” the DEA said in a prepared statement.
Then in July, DEA Administrator Michele Leonhart rejected a longstanding request to downgrade pot’s Schedule I drug status, insisting that marijuana should remain in the same category as heroin because of its high abuse potential–while arguing, despite an overwhelming scientific consensus to the contrary, that marijuana “has no currently accepted medical use in treatment in the United States,” and “lacks an acceptable level of safety for use even under medical supervision.” Yet even the National Cancer Institute begs to differ. The organization lists medical marijuana in its list of possible treatments for cancer-related pain and nausea.
But in between these two high-profile DEA actions, Britain’s giant GW Pharmaceuticals received U.S. patent approval for the use of Sativex, its nasal spray for treatment of advanced cancer pain composed of–yes, that’s right–a combination of the two primary chemicals found in cannabis. Since then, Sativex has made it all the way to Phase III clinical testing in a bid for FDA approval. At the moment, the company’s chances of producing a cannabis based pill are looking very good.
The Obama administration seems to want to have it both ways: Weed has medical benefits, but then again it doesn’t; it’s as dangerous as heroin, but safe enough to give to sick patients in medical experiments. And what about the right of the consumer to decide for herself? Whose interests are being served here, and who’s getting the shaft?
Obama seems to want to have it both ways: Weed has medical benefits, but then again it doesn’t; it’s as dangerous as heroin, but safe enough to give to sick patients in medical experiments. Whose interests are being served here, and who’s getting the shaft?
Sativex was first approved in 2005 in Canada for the relief of spasticity in multiple sclerosis–you spray the cannabis mist under your tongue for a concentrated dose of THC and cannabidiol (CBD), marijuana’s top two active ingredients. To oversimplify the science, the THC molecule is responsible for getting you high and the CBD molecule for dulling pain.
If approved, Sativex will be labeled an “add-on treatment for symptom improvement,” according to The Pharma Letter, in patients “who have not responded adequately to other anti-spasticity medication.” But once it’s on the market, doctors will be free to prescribe it off-label for use in pain caused by other conditions–and indeed for other medical problems. Our neighbor to the north was also the first to grant Sativex a conditional license for use in two of the most severe forms of pain: neuropathic, or nerve, and cancer related. Since then, Britain, Spain, Germany and other countries have given it the OK, and several giant pharmaceutical firms bought distribution rights, indicating that the industry expects this (and presumably future) treatments derived from the cannabis plant to get the legal and regulatory green light.
Add to that the fact that GW Pharmaceuticals, which grows its weed in undisclosed locations in Britain, recently wrapped up a licensing agreement with drug giant Novartis for distribution of Sativex, and the timing last month of the Justice Department’s “warning of the potential for criminal prosecutions of state employees” who go anywhere near the medical marijuana business begins to look all the more curious. It’s a fair question whether the Obama administration is subtly signaling that if there are any medical spinoffs to be discovered and delivered to citizens, the Food and Drug Administration will take it from here: Safety first. But for the thousands of Americans who already use marijuana medicinally, Sativex represents a cynical end run around the medical-marijuana establishment.
Sativex is a proprietary extract of the marijuana plant, while Spice, K2 and the other cannabis substitutes are synthetic versions of various molecules found in marijuana. Sitting uneasily between these two extremes is medical marijuana, which, like Sativex, uses the whole plant in organic form. The Sativex sell is that smoking the plant is a crude and unhealthy method of drug delivery, and that the company’s special blend delivers relief without an accompanying psychoactive “high.” Whether that’s a plus depends upon your feelings about the relatively freewheeling approach taken by the medical marijuana movement: Try smoking some of this.
The progressive website Firedoglake summed up the darker view of the fed’s strategy recently: “Demonize it, prosecute it, shut it down, then grab the market.” For legalizers, Sativex is the Trojan Horse the government will use to destroy any chance that anybody besides Big Pharma will get more than a sliver of the marijuana market when all the dust settles. They point to statements by former deputy drug czar Andrea Barthwell, who denounced medical marijuana on the grounds that “any prescriptive medicine should depend on years of careful scientific scrutiny, not whims at the ballot box by individuals who lack the qualifications to make such decisions.”
In other words, what’s wrong with medical marijuana is that the federal government does not regulate it. That’s not, by definition, an unreasonable assessment. We make the same assumption when we differentiate between hospital morphine and street heroin. But a group called Americans for Safe Access (ASA) is challenging that attitude in court. The advocacy group has spent years petitioning to change marijuana’s designation so that doctors can prescribe it to patients. “The federal government is making no bones about its aggressive policy to undermine medical marijuana,” says ASA Executive Director Steph Sherer. “And we’re prepared to take the Obama administration to court over it.”
The problem isn’t only that all these policies, taken together, are inherently contradictory. The problem is that each agency is right, up to a point. Justice and the DEA are correct to insist that certain combinations of the dozens of synthetic ingredients found in “fake” cannabis are not at all user-friendly, and that when marketed over the counter as Spice, K2, herbal incense, or bath salts, may land a consumer in the emergency room.
Yet agencies like the FDA–and entrepreneurs like GW Pharmaceuticals–are also right to insist that certain medical applications lurk within the chemical heart of the marijuana plant. “In the last three years alone,” writes Maia Szalavitz on her blog at Time Healthland, “cannabinoids have been found to help kill breast cancer cells, fight liver cancer, reduce inflammation, have antipsychotic effects and even potentially help stave off the development of Alzheimer’s disease and reduce progression of Huntington’s disease. Further, a 2011 review of the effectiveness of cannabinoids for non-cancer pain found ‘no significant adverse effects’ and ‘significant’ analgesic effects.”
It’s laudable that one department of the federal government wants to protect us from potentially harmful synthetic cannabinoids. It’s also understandable that another agency of the government wants to investigate legitimate medical applications for cannabis-based medicines. What’s confusing is the renewed fervor the Obama administration has shown for cracking down on pot-for-pain clinics in the 16 states that have legalized them. Nor is there any ready explanation for the DEA’s bad-faith declaration concerning medical marijuana, at a time when the FDA is actively testing and approving medicines based on both organic and man-made cannabis products.
The DEA’s intent [may be]to “expand the federal government’s schedule III listing to include pharmaceutical products containing naturally derived formations of THC while simultaneously maintaining existing criminal prohibitions on the plant itself.”
Although not well known, there are already several synthetic versions of cannabis available to medical patients in the U.S. HU-211, for example, a synthetic version of THC marketed as dexanabinol, is in clinical trials for glaucoma and stroke damage. HU-211 is also found as an ingredient in some versions of Spice. Dronabinol, marketed as Marinol, is a form of synthetic THC prescribed as an appetite stimulant for people with AIDS wasting or on chemotherapy, as is another form of synthetic cannabis called Nabilone. Even the government’s putatively well-meaning attack on “fake” marijuana is not entirely free of conflicts of interest.
In a pill or a spray, it’s OK. In a doobie, no way.
Back in 2005, when Canada certified Sativex, AlterNet declared: “Make no mistake: Sativex is liquid marijuana. It is nothing like Marinol, the synthetic THC pill sold in the US and sometimes falsely touted as an adequate substitute for marijuana….By approving liquid marijuana, the Canadian government has just certified that virtually everything our own government has been telling us about marijuana is wrong.” And all of this comes as the DEA and the Office of National Drug Control Policy have furiously redoubled their efforts to put a stake through the heart of the medical marijuana movement, which is attempting, more or less, to sell the same medicine.
Here is GW Pharmaceuticals’ position, which, if the FDA approves Sativex, will tacitly become the position of the US government: “GW has never endorsed or supported the idea of distributing or legalizing crude herbal cannabis for medical use. In both our publications and presentations, we have consistently maintained that only a cannabinoid medication–one that is standardized in composition, formulation, and dose, administered by means of an appropriate delivery system, and tested in properly controlled preclinical and clinical studies–can meet the standards of regulatory authorities around the world, including those of the FDA….In GW’s opinion, smoking is not an acceptable means of delivery for a medicine.”
There may be another big reason why smoking is not an acceptable means of cannabis delivery: It’s too cheap. NORML’s Paul Armentano, who frequently writes for AlterNet, says that the DEA’s intent was to “expand the federal government’s schedule III listing to include pharmaceutical products containing naturally derived formations of THC while simultaneously maintaining existing criminal prohibitions on the plant itself.” If that is truly the plan, then the conspiracy buffs have been right all along: Uncle Sam wants to be your one and only dealer–on behalf of his supplier, Big Pharma.
And with President Obama battling hard-right mudslingers in his campaign for re-election, expect him to burnish his “hard on drugs” credentials with further medical-marijuana crackdowns. For now, advocates can only hope for change in his second term. In their dreams.
Dirk Hanson has written extensively about addiction and recovery issues. He is a regular contributor to The Fix, has published The Chemical Carousel: What Science Tells Us About Beating Addiction and blogs daily at The Addiction Inbox.