SAN FRANCISCO — A quarter-century after the U.S. Food and Drug Administration approved the first prescription drugs based on the main psychoactive ingredient in marijuana, additional medicines derived from or inspired by the cannabis plant itself could soon be making their way to pharmacy shelves, according to drug companies, small biotech firms and university scientists.
A British company, GW Pharma, is in advanced clinical trials for the world’s first pharmaceutical developed from raw marijuana instead of synthetic equivalents— a mouth spray it hopes to market in the U.S. as a treatment for cancer pain. And it hopes to see FDA approval by the end of 2013.
Sativex contains marijuana’s two best known components — delta 9-THC and cannabidiol — and already has been approved in Canada, New Zealand and eight European countries for a different usage, relieving muscle spasms associated with multiple sclerosis.
FDA approval would represent an important milestone in the nation’s often uneasy relationship with marijuana, which 16 states and the District of Columbia already allow residents to use legally with doctors’ recommendations. The U.S. Drug Enforcement Administration categorizes pot as a dangerous drug with no medical value, but the availability of a chemically similar prescription drug co uld increase pressure on the federal government to revisit its position and encourage other drug companies to follow in GW Pharma’s footsteps.
“There is a real disconnect between what the public seems to be demanding and what the states have pushed for and what the market is providing,” said Aron Lichtman, a Virginia Commonwealth University pharmacology professor and president of the International Cannabinoid Research Society. “It seems to me a company with a great deal of vision would say, ‘If there is this demand and need, we could develop a drug that will help people and we will make a lot of money.”’
Possessing marijuana still is illegal in the United Kingdom, but about a decade ago GW Pharma’s founder, Dr. Geoffrey Guy, received permission to grow it to develop a prescription drug. Guy proposed the idea at a scientific conference that heard anecdotal evidence that pot provides relief to multiple sclerosis patients, and the British government welcomed it as a potential way “to draw a clear line between recreational and medicinal use,” company spokesman Mark Rogerson said.
In addition to exploring new applications for Sativex, the company is developing drugs with different cannabis formulations.
“We were the first ones to charge forward and a lot of people were watching to see what happened to us,” Rogerson said. “I think we are clearly past that stage.”
In 1985, the FDA approved two drug capsules containing synthetic THC, Marinol and Cesamet, to ease side-effects of chemotherapy in cancer patients. The agency eventually allowed Marinol to be prescribed to stimulate the appetites of AIDS patients. The drug’s patent expired last year, and other U.S. companies have been developing formulations that could be administered through dissolving pills, creams and skin patches and perhaps be used for other ailments.
Doctors and multiple sclerosis patients are cautiously optimistic about Sativex. The National Multiple Sclerosis Society has not endorsed marijuana use by patients, but the organization is sponsoring a study by a University of California, Davis neurologist to determine how smoking marijuana compares to Marinol in addressing painful muscle spasms.
“The cannabinoids and marijuana will, eventually, likely be part of the clinician’s armamentarium, if they are shown to be clinically beneficial,” said Timothy Coetzee, the society’s chief research officer. “The big unknown in my mind is whether they are clearly beneficial.”
Opponents and supporters of crude marijuana’s effectiveness generally agree that more research is needed. And marijuana advocates fear that the government will use any new prescription products to justify a continued prohibition on marijuana use. .
“To the extent that companies can produce effective medication that utilizes the components of the plant, that’s great. But that should not be the exclusive access for people who want to be able to use medical marijuana,” Americans for Safe Access spokesman Kris Hermes said. “That’s the race against time, in terms of how quickly can we put pressure on the federal government to recogni ze the plant has medical use versus the government coming out with the magic bullet pharmaceutical pill.”
Interest in new and better marijuana-based medicines has been building since the discovery in the late 1980s and 1990s that mammals have receptors in their central nervous systems, several organs and immune systems for the chemicals in botanical cannabis and that their bodies also produce natural cannabinoids that work on the same receptors.
One of the first drugs to build on those breakthroughs was an anti-obesity medication that blocked the same chemical receptors that trigger the munchies in pot smokers. Under the name Acomplia, it was approved throughout Europe and heralded as a possible new treatment for smoking cessation and metabolic disorders that can lead to heart attacks.
The FDA was reviewing its safety as a diet drug when follow-up studies showed that people taking the drug were at heightened risk of suicide and other psychiatric disorders. French manufacturer Sanofi-Aventis, pulled it from the market in late 2008.
Given that drug companies already were reluctant “to touch anything that is THC-like with a 10-foot- pole,” the setback had a chilling effect on cannabinoid drug development, according to Lichtman.
“Big companies like Merck and Pfizer were developing their own versions (of Acomplia), so all of those programs they spent millions and millions on just went away…” he said.
But scientists and drug companies that are exploring pot’s promise predict the path will ultimately be successful, if long and littered with setbacks.
One is Alexandros Makriyannis, director of the Center for Drug Discovery at Northeastern University and founder of a small Boston company that hopes to market synthetic pain products that are chemically unrelated to marijuana, but work similarly on the body or inhibit the cannabinoid receptors. He also has been working on a compound that functions like the failed Acomplia but without the depressive effects.
“I think within five to 10 years, we should get something,” Makriyannis said.
I wonder if the article was about opiates if you would use a picture of the drug or a poppy field…
Easily approved… just bring it to Main Street, Bangor, Maine!!
It’s NOT okay to use in it’s natural form….but it’s okay to form synthetics drugs out of it…..RIGHT?
I find it interesting that the U.S. Drug Enforcement Administration, a law enforcement agency, can make a statement like “Marijuana is a dangerous drug with no medical value.” Is this coming from the medical expertise department of the USDEA? How about let’s let medical experts tell us what is or isn’t medically valuable, rather than a police agency. As far as the FDA is concerned, this is the break they’ve been looking for. They can’t say a natural substance is beneficial, that would fly in the face of the pharmaceutical companies who have them in their pockets. Can’t have that. But here’s something that can be patented! Something that can make billions of dollars for them, now that’s ok!
Articles like these further prove the hypocrisy of the Federal Governments stance on medical marijuana. They argue that there is no medical benefit and yet they approve and review medications which specifically synthesize the active ingredients in marijuana like Marinol and this new Sativex. From everything I read, the Marinol did very little medicinal for the patient in comparison to raw marijuana.
So if these companies are in a rush to produce drugs with the major active ingredients of marijuana , yet the federal government’s position is that marijuana itself is not medicine despite the strong argument that it is BENEFICIAL from actual sick people. Why don’t they just come out and say what their real hang up with it is?
The government doesn’t care if you are sick, or if you can produce natural (and potentially free) medicine. They are merely bought and paid stooges of pharameceuticals companies who have patent interests so their CEO’s can stuff their garages with Ferraris and Lambo’s. WE are ALL slaves to the Prison Industrial Complex. Law enforcement are slaves to federal dollars with federal stipulations. There is too much money for the system and those who ride it to lose if an amazing natural, free medicine for the people is not kept away from them.
Remember people: natural medicine, vitamins, compounds in plants etc. are VERY VERY bad for you and totally useless to humanity unless the government approves them, or they are distributed in pill form by Pfizer, Bayer, or some other company with a copyright.
Check out evaluation of many of the “natural remedies” including the cold remedies. Not very effective and in in some cases just as toxic or with bad side effects. Besides, qulaity control on many of them is lacking.
And the intellectual property aspect is patent, not copyright. And no, you can’t patent natural products as such (big priority issue) so there’s not much incentive to develop them since anyone could use your legwork and undercut you (and possibly produce a less effective or eene dangerous product).
Yes, I would agree that not all “natural remedies” are effective, and sometimes the synthesized medications are more effective. Some natural remedies, however ARE! Particularly this one. Ask someone with M.S., cancer and cancer treatment related side-effects, glaucoma and many others if this improves their life in some way. Is that not medicine? It’s UNDOUBTABLY effective for numerous reasons. I understand you can’t patent nature (unless you genetically engineer it, or chemically synthesize it) Why the government refuses to recognize its effects unless it IS patented in some way is beyond me?
No reason to need to patent it. It’s effective as is.
Sounds like the drug companies are trying to corner the market on medical marijuana.
The last thing we need is to let pharmaceutical companies dominate this area. A natural plant that does so much to help suffering humans should not be messed with and should be left in its natural state. Marinol was useless and any drug that this could be turned into and marketed will never be as good as the plant in its natural form. Hands off pharmaceutical companies.
All the drug companies will do is add “chemicals”( who knows what kind of poison they will add) but,it will be legal because it is a drug company. Don’t forget the government allows drug companies to make a synthetic form of heroin. It’s all about corruption and money!
Sativex, at least, uses the two primary bioactive ingredients extracted from cannabis. Nothing active should have to be added.
It would seem that the main rap against smoking pot is just that: the need to smoke it. Talk about “poisonous” additives!
It doesn’t need to be smoked. It comes in many forms. But all of the latest research has disproved the myth that it is more harmful than smoking cigarettes. There is NO link between smoking marijuana and an increase of lung cancer. It’s anti inflammatory properties can actually help fight disease and has anti cancer properties.
I hope this process moves along since, as I’ve posted elsewhere, there are distinct disadvantages to using “street produced” products, especially the need to smoke pot. Extracted cannabis active ingredients (without all of the other crud) and administering it orally sounds like a very effective and safe method to use medical marijuana.
I’ll have to check out just what compositions Marinol and Cesamet are. If they’re synthetic delta 9-THC and cannabidiol, they should be more pure than the natural stuff although undoubtedly more expensive. I’ll check out that process too.
There is no evidence that there is any crud in the natural plant or that the means of administration cause any health risks. Unfortunately Marinol does not work for most people.
It’s just right the way God made it. By breaking it down and trying to synthesize only some components, you miss the overall effectiveness which only needs to be varied by plant strains in order to emphasize the desired property.