Is Big Pharma set to corner the American market on medical marijuana?
The American Independent has previously reported on the growing corporatization of the incipient medical marijuana industry at a time when medical marijuana dispensaries scrabble to hold on to their businesses in the face of a multi-pronged federal crackdown. But there are signs afoot that it just may become ever more corporate if a Big Pharma push to get the U.S. Food and Drug Administration to recognize a cannabis-derived drug is successful.
Last week, British prescription drug manufacturer GW Pharmaceuticals announced a licensing agreement with drug giant Novartis, maker of Ritalin and Excedrin, to begin selling GW’s drug Sativex in markets across Asia, Africa, Oceania and the Middle East. The medication is already available in Britain, where it’s produced and marketed by Bayer, and in Canada and Spain. It’s on the market in those countries as a liquid that patients spray under the tongue and is prescribed primarily for sufferers of multiple sclerosis and cancer.
Sativex: Liquefied marijuana
If the name “Sativex” rings a distant bell, that’s because it’s derived from Cannabis sativa, the scientific name for the plant from which both hemp and marijuana are harvested. It’s an appropriate name because, unlike other cannabinoids produced for recreational and medicinal use (and plagued by side effects not present in natural cannabinoids), Sativex is not a synthetic concoction, but essentially liquefied marijuana. It’s an extract of whole-plant cannabis that includes the psychoactive agent THC as well as cannabidiol (CBD), the chemical thought to be responsible for some of the anti-nausea and cancer-cell-killing effects of medical marijuana.
While the official word from GW is that the THC and CBD balance each other out to provide marijuana’s medicinal effects without an accompanying high, cannabis expert and professor emeritus of psychiatry at Harvard Medical School Dr. Lester Grinspoon has said just upping the dosage would provide the same effects as recreational marijuana.
Early in Sativex’s development, GW hired Dr. Andrea Barthwell as a consultant to sing the drug’s praises, although she’s no longer in the employ of GM. Barthwell was a deputy drug czar under George W. Bush and is the former president of the American Society for Addiction Medicine (ASAM). In a recent ASAM press release, Barthwell denounced medical marijuana but — significantly — only because it was unregulated by the federal government.
“The safety and advisability of 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. Allowing cannabis to circumvent FDA approval sets a dangerous precedent and puts us on a slippery slope,” Barthwell says in the release.
“There’s certainly an inconsistency in the fact that she speaks publicly about the negative impact of marijuana even though she’s been paid by a company that sells it,” says Steve Fox, chief lobbyist for the National Cannabis Industry Association (NCIA). “It would be one thing if she were representing the American Society Against Bronchitis and said, ‘I am so concerned that people are smoking a substance that’s not good for their bronchial tubes.’ But she’s speaking for the ASAM.”
Meanwhile, Sen. Richard Burr (R-N.C.), Congress’s top recipient of campaign funds from the pharmaceutical industry, has come out against state medical marijuana laws, despite being an advocate of states’ rights on issues like allowing offshore drilling. The likes of Barthwell and Burr have drawn the ire of supporters for the reform of marijuana laws who believe that they represent the pharmaceutical industry’s goal for medical marijuana: demonize it, prosecute it, shut it down, then grab the market.
(Neither Barthwell nor Burr was available to comment for this story at the time of publish.)
Certainly, such a fight would benefit from proclamations like Barthwell’s distinction between government-approved drugs derived from cannabis and unregulated cannabis itself, as well as the National Cancer Institute’s recognition (later qualified) of the medical benefits of marijuana. That could be exactly what GW is banking on as it works with companies to expand the availability of Sativex around the world. And the one major market left untapped by either Novartis or Bayer (GW’s partners in making and selling Sativex) is the United States. That’s where Otsuka Pharmaceutical comes in.
Otsuka, America’s potential Sativex supplier
Otsuka is an international prescription drug company based out of Japan. In 2007, GW and Otsuka announced that the latter company would be taking on clinical trials for Sativex in the U.S. In November of last year, Otsuka wrapped up its Phase II trials testing the drug’s efficacy and safety and met with the FDA to discuss the next step in getting the drug recognized by the federal agency. Phase III was then set to begin, though Otsuka’s website for the Phase III trials indicates that they’re still being set up.
Otsuka declined to comment to The American Independent on how close Sativex is to FDA approval or how far along the Phase III trials are, but Phase III is typically the final step in a drug’s path to pharmacies. Even getting to Phase III means the FDA has signed off on earlier test results and needs to see them confirmed in a large-scale study before advancing the drug. For its part, the FDA does not comment on ongoing clinical trials.
Pharmaceutical insiders would claim that Sativex is simply a regulated, tested cannabinoid that is demonstrably safe in ways that black-market and state-legal whole-plant medical marijuana isn’t. And yet by its very definition (PDF), Sativex is marijuana, albeit with a lower THC count in the recommended dose than is present in the raw plant.
Can pharmaceutical clout bring FDA approval?
So how are pharmaceutical companies looking to succeed where medical marijuana dispensaries are failing in getting marijuana recognized by the FDA without any federal agencies breathing down their necks? One answer could be in the clout the industry holds in Washington.
The pharmaceutical industry is far and away the biggest spender on federal lobbying. Between 1998 and 2010, Big Pharma spent more than $2 billion sending lobbyists to the capital to fight for industry-friendly legislation and regulations. This is over half a billion more than the amount spent in the same period by pharmaceuticals’ closest competitor, the insurance industry, and nearly twice what oil and gas companies spent. The medical marijuana lobby, less than six months old and consisting almost entirely of Steve Fox (backed by NCIA director Aaron Smith and a handful of dispensary owners and enthusiasts), could never compete.
All this puts the surging federal clampdown on medical marijuana in a new light. As nationwide support for medical marijuana reaches record levels, it may just be the pharmaceutical industry that rides that wave of support to huge profits.
And what do we do with Alcohol? Just leave it as it is? Why? Those reasons apply equally with Cannabis. Cannabis should be completely Legal for responsible adults and for all in the medical way.
Guess they’ll legalize it once Big Pharma has its ducks in a row.
Kind of like nat gas drlg discouraged until Big Oil buys out all the nat gas production companies.
Legalize weed. Free Phil: 25-30 yrs Federal for weed ! ! Not murder, weed
You did not mention the fact that all these companies involved are licensed by the US DEA. Which makes them private contractors or they have a private army globally. The W in GW comes from David Watson (& Goffrey Guy)
The company was founded in 1998 on the prospect of the 1997 introduced Ice-Water-Method, which is assumed to be used in the early stages, as company statements indicate. David Watson is co owner of Hortapharm, Ne,
Involved in the Canadian Sativex deal. You can read more http://www.kingofnepal.net The articles “Icewars” and “Operation Green Merchant” describe the now “grobots case”, …….. Reinhard
[...] of the National Organization for the Reform of marijuana Laws (NORML), wrote at AlterNet. h/t: The American Independent GS_googleAddAdSenseService("ca-pub-9888434945255495"); GS_googleEnableAllServices(); [...]
Here is a little more information that helps connect the dots. Former HHS Secretary Micheal Leavitt held the position when HHS was grated United States Patent 6630507 on 7-Oct-2003. Cannabinoids as Antioxidents and Neuroprotectants. I read the patent and it is quite ingeneous. The cannabinoids and any new molecule they can make from the cannabinoids are patented. The Schedule I “no medical value” argument was negated by this official act. The DEA has stalled on review of marijuana for re-scheduling for years. Micheal Leavitt’s company is poised to help new medical business. link below.
Does anyone else think we will see a tie between this story and Mr. Leavitt’s new entiprise in the near future?
[...] h/t: The American Independent [...]
[...] The American Independent Share the Posted in Cannabis Sativa | Tags: Cannabis, Marijuana, [...]
[...] So Sativex is hitting new markets across the world, below is an article re the US market – Is Big Pharma set to corner the American market on medical marijuana? | The American Independent Those of us who are in the UK and suffer from MS should be able to get it – but according to the [...]
I just want to smoke a bowl and get a buzz. Get your big Pharma nose out of my high.