Medical pot activists fear new Epilepsy drug will undercut them
G W Pharmaceuticals is the maker of Epidiolex, an almost pure extract of cannabidiol, or CBD. The drug contains very little tetrahydrocannabinol, or THC, that gives marijuana users a high.
The CBD in medical pot products are what is fueling the current rage today, and activists are fearful that if the FDA does approve Epidiolex for use, the move will adversely affect the political momentum of the medical marijuana movement. The drug company says that if Epidiolex is approved, it will be the first drug in the U.S. containing CBD to get approval.
The Associated Press reports that Dr. Anup Patel, a pediatric neurologist who oversees Epidiolex clinical trials at Nationwide Children’s Hospital in Columbus, Ohio, points out the drug contains the optimal known amount of CBD for treating seizures. He also cited a study that found children can be hurt by using the whole plant.
Patel went on to say that the thing that upsets him the most is that children are being used to push for medical marijuana legalization in the U.S., even though Ohio knocked legalization down when it was on the ballot last year. “People are mixing terms, mixing ideas,” the Herald Online quoted him as saying. “I’m not sure if that’s just because of confusion, lack of knowledge or on purpose.”
Two warring camps on the issue of medical marijuana
One camp or side of the issue is the opinion held by traditional medical marijuana users. They say that an individual knows what is best for them, regardless of if they smoke, use an oil vaporizer pen or use flowered products or the oil. As activists, they want to protect their ability to do just that.
This is why they are afraid of the big pharmaceutical companies getting involved in medical marijuana because they would lose the right to dose themselves. But they are ignoring the people, such as children and the elderly, that really can benefit from the extracts of marijuana, who may not know how or be able to make the concentrations themselves.
The other camp in this issue wants to see more scientific validity and real studies done on the optimal concentrations needed in dosing. They say this will give reliability to the products. They also point out the cost of medical marijuana products, which cost from about $100 to more than $1,000 per month. These costs are not covered by most medical insurance policies, but a drug like Epidiolex, which would cost from $2,500 to $5,000 a month, could be covered by most insurance policies.
Epidiolex has proven to be an effective treatment for one rare form of epilepsy called Dravet Syndrome and is just one in a line of marijuana-based medications on the market. G W Pharmaceuticals also manufactures Sativex, a drug that treats multiple sclerosis spasticity. Sativex contains a specific extract of Cannabis, nabiximols, that was approved as a botanical drug in the United Kingdom in 2010 as a mouth spray.
The bottom line for this issue is that activists fear Epidiolex approval will mark the beginning of Big Pharma’s takeover of the marijuana plant, taking away a patient’s ability to treat themselves as they see fit.
Filed under: General Problems
I think what part of the hesitancy with the government allowing the free growth and utilization of Cannabis is that it is a plant with medicinal properties. The fear is that if the citizenry are able to take back the right to grow, trade and utilize Cannabis without the overreaching, ham-handedness of Big Brother…then this will create a precedent for other medicinal plants…like Papaver somniferum and Erythroxylum coca. Now I don’t have a huge problem with that concept so long as the effective alkaloids are confined to their natural forms to be used medicinally. That’s how these plants were used as medicinals in an ethnobotanical sense for thousands of years. Coca leaves are chewed or made into a tea for their medicinal effects and the Inca and other indigenous peoples of the Andes did not have the problems that occurred later when Cocaine HCl and Cocaine HC03 were isolated and purified. the same goes for Papaver and it/s manifold alkaloids being isolated and modified. So someone cries out that if the plants are decriminalized, then it’ll be anarchy. I’m thinking, “No”. It can’t be any worse than the results of 46 years of this asinine, failed public policy known as the war on drugs.
In 1905, when Congress passed the Pure Food and Drug Act and the President signed it into law, for all the alleged good that such a law was supposed to do, the most insipid and pernicious thing that resulted was the United States Federal Government now having the de juris authority to dictate what an individual may or may not ingest into their own body. We, as a people, lost the right to self-determined personhood with the strole of a pen. it’s only taken a little over a century to see what the results of that have been. That hasn’t worked out to well for us. Given the dollar as the motive, the private sector has shown the ability to create better public policy than the State.
At the end of the day, Government by the State apparatus always metastasizes into a belligerent bully that has a lust for the acquisition and control of the society’s capital and for absolute power. Look at history. It has always been this way as far back as recorded history is able to demonstrate. It will get to the point that the people will have had enough and the current government will either collapse or be overthrown. There will be untold amounts of death and pestilence and a new and supposedly improved statist government will arise from the ashes, wash rinse, repeat. I’m not an anarchist, but at the same time, I think that there has to be some other system of societal order that does not include the State. Until then, there needs to be a mechanism that checks the malignant growth of it. Our Founders had the right idea, but there was not a robust enough system to keep the lust for money and the power that is bought with such in check. BTW, I have no problem with money and wealth, in and of itself. The apostle stated that it’s the “love of money” that is the root of all evil and not money itself.
Now the people who presume to rule over us just ignore the safeguards put in place and there is no accountability. Until we, as a people, address this fundamental flaw and assert our Natural Right to say, “NO!”, we will continue to have fiascos like the failed War on Drugs and bureaucrats presuming to dictate to us that they, and not us, determine the ultimate rights to what we do with ourselves as individuals.
And here just a few years ago, Big Brother was telling us that “pot” was the “gateway drug” to “harder drugs” (*rolls eyes*) … Sorry, I couldn’t resist taking a jab at the dummies known as the US government. In all seriousness, I had no idea mmj could be that expensive.
I live in a state where it’s still banned (oh, yeah, and Kratom is banned … and we still drive horse and buggies). It’s been a long time since I’ve smoked (for recreational purposes), but it is still beyond ridiculous that a harmless plant is still banned all while tobacco and alcohol are legal (In no way am I suggesting further restrictions, taxes, or banning of those two substances. Just pointing out the hypocrisy).
Truthfully, if I wasn’t subjected to random drug testing at my doctor’s office, I would bite the bullet and have my son get me some to help me sleep. My doc currently gives me temezapam, but I’m just waiting for him to take it away since all the ridiculous warnings on taking benzos and “opioids” together. (Never mind the fact that I’ve taken both for years and never od’d yet. Maybe it’s cause I pay attention to directions and don’t mix them with alcohol or other potentially harmful substances).
I’m with Bob and Chippy – each adult should not have their rights infringed upon on what they can and can’t do in the privacy of their own house (short of putting others at immediate risk), especially when it comes to growing a harmless plant. (Ex: It’s one thing to mix dangerous chemicals in your house to make meth because meth lab explosions can and do happen, but growing a plant? No danger there.)
Actually, cannabis does not have to be rescheduled for this drug to come to market. It is made by GW Pharmaceuticals in the UK. They have a cultivation license there (an exclusive license if I remember correctly). They also produce Sativex, a standardized extract of cannabis.
The solution to most legal problems, is to identify the proper law to apply.
What the activists are seeking here is the ability to make their own medicinal herb products, and use them as they see fit, just in case the Pharma drug turns out to be too expensive or to have side effects that they can overcome by making an herbal remedy at home.
There’s a name for this idea.
The name is Self-Defense.
These activists want to protect themselves against the FDA or a Pharma firm, fouling up their work.
No American police agency is 100% effective at preventing violent crime. In fact, every such agency says that it’s main job is to catch criminals after they commit a crime and get them prosecuted for it…any prevention that happens, results from a crook being locked up and unable to commit crimes while locked up.
Similarly, FDA is not 100% effective at preventing problems with prescription medicines.
Americans who want to defend our homes against crime, are free to buy locks, burglar bars, safes, vaults, alarm systems, and defensive weaponry. Our Supreme Court has ruled that the purpose of the Second Amendment to our Constitution, is to affirm the right to defend oneself and to acquire the means to do so.
Following the Court’s logic, what these activists need to do, is to assert that medicinal plants are property they use for self-defense against a disease. Growing and processing these plants, is as much an individual right, as choosing to keep a gun in one’s house. Makers of medicinal products can certainly compete with each other to sell the best product. But what should not happen, is that the maker of one product pays a team of lobbyists to influence legislators and buys a statute or a regulation, that obstructs anyone from making a better product and competing with that maker.
Getting CBD established as a medicinal substance, would force changes to the Controlled Substances Act, because it is absolutely necessary to grow and harvest cannabis plants, as the raw material for CBD. The present Schedule I designation of cannabis, applies only to toxins that have no medicinal use. CBD, by acquiring a medicinal use, forces cannabis to be rescheduled, to at worst, Schedule II.
Dr Patel misses an important fact about the Ohio election results. What Ohio voters rejected, was a proposal from a used car salesman, that he and 9 other people be granted a monopoly over all cannabis medicinal products grown or used in Ohio. This is exactly the situation that activists fear, in the other 49 states, if a Pharma company got a monopoly over CBD. Pro-cannabis Ohio voters, voted against the monopoly plan, because they feared a monopoly.
Preventing the harm that a cannabis monopoly would cause, requires that we speak up about the precise legal right we seek to defend…in this case, the right to defend ourselves from a disease. There should not be a cannabis monopoly because granting one, obstructs us from making better medicines that rely on cannabis ingredients. We need to say that.
Grow your own, screw the FDA.