My blog is dedicated to the exploration of industrial hemp in America including the rich history of all forms of cannabis, the evolving law and politics of hemp and marijuana, the many products made from cannabis and the capacity, real or imagined, of hemp to re-industrialize rural America and revitalize the American family farm.
Tuesday, December 12, 2017
Big Pharma Vs Hemp Based CBDs and Medical Marijuana
The legal status of CBD oil, as a nutritional supplement is being threatened by Big Pharma seeking FDA approval for CBD-containing drugs
The cannabinoids in cannabis, cannabidiol (CBD) and tetrahydrocannabinol (THC), interact with the human body by way of naturally-occurring cannabinoid receptors embedded in cell membranes throughout.
Scientists believe the endocannabinoid system may represent the most widespread receptor system in the human body.
The fact is that here are cannabinoid receptors in the brain, lungs, liver, kidneys, immune system and more, and both the therapeutic and psychoactive properties of Marijuana occur when a cannabinoid activates a cannabinoid receptor.
The human body actually makes its own cannabinoids, similar to those found in Marijuana in much smaller quantities than one would get from the plant.
The fact that the body is replete with cannabinoid receptors, Key to so many biological functions, is why there is an enormous medical potential for Cannabis.
Mostly, Medicinal Marijuana is made from plants bred to have high CBD and low THC content. While THC has psychoactive activity that can make one feel high, CBD has no psychoactive properties.
That does not mean THC is medicinally useless.
It has been found to have a number of medicinal benefits, although it does need to be balanced with CBD, to lessen its psychoactive effects.
Recent animal research suggests THC has a beneficial influence on the aging brain. Rather than dulling or impairing cognition, THC appears to reverse the aging process and improve mental processes, raising the possibility it might be useful for the treatment of dementia.
In a recent report we learned that Big Pharma, aka the drug industry, is pushing for legislation that would make CBD oil illegal by turning it into a drug.
The report discusses a South Dakota Senate bill, SB 95, which would exempt CBD from the definition of Cannabis, thereby transferring it from a Schedule I controlled substance to a Schedule IV substance. Thus, allowing CBD products to be sold legally in South Dakota, where Medicinal Marijuana is not allowed.
Last Summer, lobbyists for GW Pharmaceuticals (NASDAQ:GWPH), and its US subsidiary; Greenwich BioSciences, fought for an amendment to the bill that would have limited CBD rescheduling to products approved by the Food and Drug Administration (FDA), in other words, they wanted only CBD drugs to be legally obtainable.
“Not surprisingly, GW Pharmaceuticals has just such a drug in the pipeline. Epidiolex, a ‘proprietary oral solution of pure plant-derived cannabidiol,’ has already been given to epileptic children in the U.S. as part of a federal investigative study documented recently in the New England Journal of Medicine.”
Epidiolex is currently under FDA review for approval.
Notable: “Since no other pharmaceutical company has a CBD drug anywhere close to market, and the wide range of CBD products already available in medical marijuana states lack FDA approval, if the bill had passed with that amendment intact, patients in South Dakota would have been subjected to a virtual CBD monopoly …
More ominously, The Great CBD Battle of South Dakota appears to be but the opening salvo in a nationwide war between GW Pharmaceuticals and traditional medical Cannabis providers …
[U]nder the amendment, South Dakota would … ban myriad CBD products already available in many other states. Even though they cost far less than Epidiolex, and are potentially more effective for patients, since in addition to CBD those “full spectrum” cannabis extracts also contain small amounts of THC and other medicinal components of the plant.”
Full spectrum Cannabis extracts will not be pure CBD, as they’re derived from the whole plant. And, as noted by CNN medical correspondent Dr. Sanjay Gupta, “ … [E]vidence is mounting that these compounds work better together than in isolation.”
It’s possible that “pharmaceutical strength” CBD might be too pure, hence the high rate of side effects.
Regardless, there’s a significant difference in cost between a CBD drug and natural CBD oil, which in and of itself is of great concern for many patients and their families who now worry Big Pharma is trying to take over the Cannabis industry.
Medical Cannabis might be “Too Good.”
Showing promise for a wide range of ailments, the drug industry sees Cannabis as major competition, and rightfully so.
In South Dakota, a scaled-back amendment to SB 95 was ultimately signed into law. South Dakotans who want legal access to CBD will still have to wait until Epidiolex gains FDA approval, but GW Pharmaceuticals was not successful in limiting the down-scheduling of CBD to FDA approved CBD drugs only.
As a result, GW Pharmaceuticals will not have a monopoly on the market. But, GW Pharmaceuticals has contracted lobbyists in several different states to fight for its cause, and their combined efforts may delay implementation of Cannabis reform that could improve access to Medicinal Marijuana.
In related news
Indiana Governor Eric Holcomb recently announced CDB oil containing THC, regardless of the amount, will no longer be legal in the state, and has instructed local police to “perform normal, periodic regulatory spot checks of CBD oil products.” Retailers were given 60 days to sell out or remove such products from their stores.
According to the data: Most of the CBD products being sold in Indiana contain less than 0.3% THC, meaning they cannot produce a ‘high’.
Advocates of CBD oil say those products do not have as many benefits as full spectrum CBD oil products.
Indiana law only allows CBD products to be used by epileptic patients, who must register with the state’s CBD oil registry.
Republican state Senator Jim Tomes vows to introduce legislation that would expand access to CBD oil under state law. “He’s received calls from people who’ve used the product to treat arthritis, Parkinson’s disease and mental illnesses.” Sen. Tomes told reporters, “I just don’t understand why is there such a resistance to allow people to get this product here? You can’t abuse it. It either works or it doesn’t.”
The answer to Senator Tomes’ question appears to be drug industry pressure, as follows:
“Indiana Attorney General Curtis Hill Jr. appears to be relying on a discredited opinion from the federal Drug Enforcement Agency on the legality of the hemp-derived cannabinoid, which must come from industrial hemp that contains less than 0.3% THC (the high-inducing cannabinoid).
The 21 November advisory opinion was issued from the state capital of Indianapolis, which also happens to be the headquarters of pharmaceutical giant Eli Lilly & Co.(NYSE:LLY), which is seeking fast-track approval from the FDA for its non-opioid painkiller drug, tanezumab.
‘As a matter of legal interpretation, products or substances marketed for human consumption or ingestion, and containing cannabidiol, remain unlawful in Indiana, and under federal law,’ AG Hill wrote in his opinion. This conclusion does not apply to any product that is approved by the FDA.
There are currently 2products that contain cannabidiol undergoing clinical trials;
1. Epidiolex and
Simply put, cannabidiol is a Schedule I controlled substance because marijuana (Cannabis sativa) is a Schedule I controlled substance.
The primary confusion appears to center around the fact that state law permits CBD as long as it is sourced from hHemp and not Marijuana.
In an effort to resolve the problem, the Hemp industry has held educational meetings to explain the differences between Marijuana and Hemp-derived CBD products.
The campaign resulted in Indiana State Police issuing a statement saying that CBD products are legal in Indiana as long as they are sourced from Hemp.
Further, the FDA is also increasing its scrutiny of companies making CBD products.
As reported recently, 4 Colorado businesses have received FDA warning letters for making “illegally unsubstantiated health claims” on their CBD products.
In a November 1 press release, the FDA said:
“[T]he agency today issued warning letters to 4 companies illegally selling products online that claim to prevent, diagnose, treat, or cure cancer without evidence to support these outcomes … The deceptive marketing of unproven treatments may keep some patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.
The FDA has grown increasingly concerned at the proliferation of products claiming to treat or cure serious diseases like cancer. In this case, the illegally sold products allegedly contain cannabidiol (CBD), a component of the marijuana plant that is not FDA approved in any drug product for any indication.”
The warning letters rejected claims that CBD oil can be classified as dietary supplements, as Investigational New Drug (IND) applications have been submitted for the CBD-containing drugs Sativex and Epidiolex, both by GW Pharmaceuticals.
This suggests the agency is not just aiming to clean up the Cannabis industry’s making illegal claims; it also raises concerns that the legality of all CBD products is in question now that CBD-containing drugs await FDA approval.
While CBD has now been reclassified to a Schedule IV substance in North Dakota by excluding it from the state’s definition of Marijuana, it still remains a Schedule I (illegal) controlled substance in most other states.
This is of great concern, considering the evidence showing Medical Marijuana lowers Rx (prescription) drug use.
There are no compelling reasons why addictive narcotics like OxyContin are legal, while Marijuana, which is extremely unlikely to kill a person even if taken very high amounts, is not.
The video above features W. David Bradford, PhD., whose study was published in the journal Health Affairs in July 2016.
As reported by The Washington Post:
“[R]esearchers at the University of Georgia scoured the database of all prescription drugs paid for under Medicare Part D from 2010 to 2013. They found that, in the 17 states with a medical-marijuana law in place by 2013, prescriptions for painkillers and other classes of drugs fell sharply compared with states that did not have a medical-marijuana law.
The drops were quite significant: In medical-marijuana states, the average doctor prescribed 265 fewer doses of antidepressants each year, 486 fewer doses of seizure medication, 541 fewer anti-nausea doses and 562 fewer doses of anti-anxiety medication. But most strikingly, the typical physician in a medical-marijuana state prescribed 1,826 fewer doses of painkillers in a given year.”
According to Dr. Bradford, the Medicare program could save $468-M annually if Marijuana were legalized in all US states.
Already, $165-M was saved in Y 2013 in the 18 states where medical Marijuana was legal that year. Similarly, a Y 2015 paper by The National Bureau of Economic Research (NBER) states that:
“If marijuana is used as a substitute for powerful and addictive pain relievers in medical marijuana states, a potential overlooked positive impact of medical marijuana laws may be a reduction in harms associated with opioid pain relievers, a far more addictive and potentially deadly substance.”
Not only did the NBER find that access to state-sanctioned Medical Marijuana dispensaries resulted in a significant decrease in prescription painkiller overdose deaths, it also led to a 15 to 35% decline in substance abuse admissions.
So, it would seem Medical Marijuana could actually save thousands of lives that would otherwise be destroyed by painkiller addiction and its lethal consequences.
It is alarming that the US government is so willing to shell out taxpayer money to Big Pharma for addictive painkillers and the drugs to treat addiction when a safe and effective answer to the pain and opioid epidemics lies right before us.
The published data show that older Americans are becoming increasingly converted to Marijuana use.
Between Y’s 2006 and 2013, use among 50 – 64-year-olds rose by 60%. Among seniors over 65, use rose by 250%.
Pain and sleep are among the most commonly cited complaints for which medicinal marijuana is taken.
Considering the high risk of lethal consequences of opioid painkillers and sleeping pills, medical marijuana is a natural blessing.
As noted by Dr. Margaret Gedde, an award-winning Stanford-trained pathologist and founder of Gedde Whole Health, there’s enough scientific data to compare the side effects of Cannabis Vs the known toxicities of many drugs currently in use. This includes liver and kidney toxicity, gastrointestinal damage, nerve damage and death.
Cannabidiol has no toxicity and it’s virtually impossible to die from Marijuana.
It is self-limiting, as excessive doses of THC will provoke anxiety, paranoia and nausea. Such side effects will disappear as the drug dissipates from the human system without resulting in permanent harm, but it will make one think 2X about taking such a high dose again. Make the same mistake with an opioid, and chances are the user ends up in the city morgue.
Dr. Gedde also notes that Cannabis products often work when other medications fail, so not only are they safer, they also tend to provide greater efficacy.
In Y 2010, the Center for Medical Cannabis Research (CMCR) released a report on 14 clinical studies about the use of Marijuana for pain, most of which were FDA-approved, double-blind and placebo-controlled. The report revealed that Marijuana not only controls pain, but in many cases, it does so better than pharmaceutical alternatives.
Reputable information about Cannabis can be hard find, but not impossible.
A good source is cancer.gov, the US government’s site on cancer. Simply enter “Cannabis” into the search bar, and peruse the medical literature through PubMed, which is a public resource.
CMCR also provides a hyperlinked list of scientific publications relating to a wide variety of medicinal uses of Cannabis, and the Journal of Pain, a publication by the American Pain Society, has a long list of studies on the pain-relieving effects of cannabis.
According to the National Institute on Drug Abuse, which also has information relating to the medicinal aspects of marijuana, pre-clinical and clinical trials are underway to test Marijuana and various extracts for the treatment of a number of diseases, including autoimmune diseases such as multiple sclerosis and Alzheimer’s disease, inflammation, pain and mental disorders.
Awareness is starting to shift, and many experts are starting to recognize the medical value of Cannabis.
That also means the drug industry is doing everything it can to secure its place in the market, and in so doing, eliminating the legal use of natural and far less expensive Cannabis products.
So, it is up to The People to stay involved in the political process whenever Marijuana-related legislation is brought up. If not, you can be sure the drug industry will take it over and what is inexpensive and natural will become expensive and pharmaceutical.