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.

In a letter yesterday to GAO, Reps. Henry Waxman (D-Calif.), Charlie Rangel (D-N.Y.), Pete Stark (D-Calif.) and John Lewis (D-Ga.) voiced concerns that the companies are “artificially raising prices for certain pharmaceutical products in expectation of new reforms that could otherwise reduce prescription drug prices or price growth by encouraging patients and the government to be more efficient purchasers.”

Any price gouging is unacceptable, but anticipatory price gouging is especially offensive. We request that the GAO prepare on an expedited basis a report that analyzes recent trends in prescription drug pricing. In addition, we request that you prepare a proposal to ensure ongoing monitoring of pharmaceutical manufacturer pricing practices, and periodically report to the Congress on your findings.

Not that the pharmaceutical industry is taking the Times’ report sitting down. In a statement released Monday, Ken Johnson, senior vice president of the Pharmaceutical Research and Manufacturers of America, said the price increases represent “the natural result of market forces.”

“Even with PhRMA’s offer to help seniors,” says Dorgan, “American consumers will continue to pay the highest price for prescription drugs in the world.”

“The fact is,” adds Snowe, “that while the announced savings are substantial, they amount to less than 4 percent of our nation’s annual prescription drug spending, and when you consider that other developed nations pay 35-55% less for their medications, it certainly doesn’t close the gap much.”

For years, the two lawmakers have pushed legislation — anathema to drug companies — allowing U.S. pharmacists to import Food and Drug Administration-approved drugs from some countries abroad, where costs are much lower, and pass the savings on to domestic consumers. (Current law limits the importation of prescription drugs exported by the United States).

Obama, as senator, was a sponsor of the same bill. By agreeing to take an estimated $80 billion haircut under Medicare’s drug benefit, however, the drug makers are surely hoping to stave off further cuts, like the Dorgan-Snowe bill certainly represent.