February 9, 2012
Hypocritical? Approval Process Underway For Prescription Pills Made From Raw Marijuana
We all knew this was coming. In a very hypocritical turn of events, after the U.S. federal government decreed that marijuana had no accepted medical value last year, the U.S. Food and Drug Administration (FDA) is now on pace to approve the first prescription drugs based from raw marijuana by 2013.
Health benefits of marijuana are now well documented. From depression and anxiety relief to reduced blood pressure, pain alleviation, glaucoma and cancer treatment.
Marijuana has been approved by California, many other states and the nation's capital to treat a range of illnesses, but last summer the federal government officially declared that marijuana has no accepted medical use.
Now, a British company, GW Pharma, is in advanced clinical trials for the world's first pharmaceutical developed from raw marijuana instead of synthetic equivalents and they say they'll have a mouth spray to treat cancer pain on pharmacy shelves by 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.
Government entities have always known that accepting and promoting the powerful health benefits of marijuana would instantly cut huge profits geared towards cancer treatment and the U.S. would have to admit it imprisons the population for no cause. Nearly half of all drug arrests in the United States are for marijuana.
According to MarijuanaNews.com editor Richard Cowan, the reason why cannabis has been suppressed is because it is a threat to cannabis prohibition "....there really is massive proof that the suppression of medical cannabis represents the greatest failure of the institutions of a free society, medicine, journalism, science, and our fundamental values," Cowan notes.
The U.S. Drug Enforcement Administration still categorizes pot as a dangerous drug, but the availability of a chemically similar prescription drug could 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.'"
In 2003, the U.S. Government as represented by the Department of Health and Human Services filed for, and was awarded a patent on cannabinoids. The reason? Because research into cannabinoids allowed pharmaceutical companies to acquire practical knowledge on one of the most powerful antioxidants and neuroprotectants known to the natural world.
The U.S. Patent 6630507 was specifically initiated when researchers found that cannabinoids had specific antioxidant properties making them useful in the treatment and prophylaxis of wide variety of oxidation associated diseases, such as ischemic, age-related, inflammatory and autoimmune diseases. The cannabinoids are found to have particular application as neuroprotectants, for example in limiting neurological damage following ischemic insults, such as stroke and trauma, or in the treatment of neurodegenerative diseases, such as Alzheimer's disease, Parkinson's disease and HIV dementia. Nonpsychoactive cannabinoids, such as cannabidoil, are particularly advantageous to use because they avoid toxicity that is encountered with psychoactive cannabinoids at high doses useful in the method of the present invention.
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.
"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.
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 recognize 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.
Scientists and drug companies that are exploring pot's promise predict the path will ultimately be successful, if long and littered with setbacks.
Marco Torres is a research specialist, writer and consumer advocate for healthy lifestyles. He holds degrees in Public Health and Environmental Science and is a professional speaker on topics such as disease prevention, environmental toxins and health policy.