Big Pharma making moves to monopolize CBD oil market

December 11th, 2017

Awake Goy

The cannabinoids in cannabis – cannabidiol (CBD) and tetrahydrocannabinol (THC) – interact with your body by way of naturally-occurring cannabinoid receptors embedded in cell membranes throughout your body. In fact, scientists now believe the endocannabinoid system may represent the most widespread receptor system in your body.¹

There are cannabinoid receptors in your 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. Your body actually makes its own cannabinoids, similar to those found in marijuana, albeit in much smaller quantities than you get from the plant.

The fact that your body is replete with cannabinoid receptors, key to so many biological functions, is why there’s such enormous medical potential for cannabis. More often than not, medicinal marijuana is made from plants bred to have high CBD and low THC content. While THC has psychoactive activity that can make you feel “stoned,” CBD has no psychoactive properties.

That doesn’t mean THC is medicinally useless, however. It too has been found to have a number of medicinal benefits, although it does need to be balanced with CBD to lessen its psychoactive effects. For example, recent animal research² suggests THC has a beneficial influence on the aging brain.^3,⁴ 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.⁵

Drug Company Vies for CBD Monopoly

As reported by Motherboard, the drug industry is now pushing for legislation that would make CBD oil illegal – by turning it into a drug.⁶The article 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. This would allow CBD products to be sold, legally, in South Dakota, where medicinal marijuana is currently not allowed.

This past summer, lobbyists for GW Pharmaceuticals and its U.S. 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.” Motherboard writes. Epidiolex is currently under FDA review for approval.

“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.“

Study Confirms CBD Benefits for Drug-Resistant Seizures

The randomized, double-blind, placebo-controlled study⁷ published in The New England Journal of Medicine in May 2017 again confirmed what has long been known: that CBD offers relief for children with drug-resistant seizures, in this case patients diagnosed with Dravet syndrome, a “catastrophic early-onset encephalopathic epilepsy, with a high mortality rate.”

GW Pharmaceuticals funded the study and was responsible for the trial design. The company also supplied the CBD and placebo. The active treatment was an oral solution containing 100 milligrams (mg) of CBD per milliliter, given in addition to the child’s current antiseizure medication regimen. The placebo was identical to the treatment solution, but without CBD.

The dose was gradually increased over the course of 14 days, with a maximum dose of 20 mg per kilogram of body weight, taken twice a day. At the end of the treatment period, the CBD solution was tapered down over the course of 10 days, reducing the dosage by 10 percent each day. Following is a summary of the main findings:

Children taking CBD experienced a nearly 40 percent reduction in the frequency of convulsive seizures over the 14-week treatment period, from a median of 12.4 seizures per month to 5.9. In the placebo group, the median convulsive-seizure frequency decreased from 14.9 to 14.1
43 percent of patients in the CBD group experienced a 50 percent or greater reduction in convulsive-seizure frequency, compared to 27 percent in the placebo group
During the treatment period, three patients in the CBD group were completely free of seizures. No patients in the placebo group were free of seizures
When looking at all seizure types, the median frequency of seizures per month decreased from 24.0 to 13.7 in the CBD group (a reduction of 28.6 percent), compared to a decrease from 41.5 to 31.1 in the placebo group (a reduction of 9 percent)
37 of 60 caregivers (62 percent) said their child’s overall condition improved in the CBD group, compared to 20 of 58 caregivers (34 percent) in the placebo group

Reported Side Effects

Interestingly, while medical cannabis is typically well-tolerated, with few side effects, a whopping 93 percent of children in the CBD group – as well as 75 percent of those in the placebo group – suffered adverse events in this trial.

Eighty-four percent of adverse events in the treatment group were deemed mild or moderate, and included vomiting, fatigue, fever, upper respiratory tract infection, decreased appetite, convulsions, lethargy, drowsiness and diarrhea. Eight patients in the treatment group withdrew from the study due to side effects.

Of course, these conventional investigators were clueless about the benefit of a ketogenic diet for the treatment of seizures, so that was something that was not evaluated in the study. This is unfortunate, as it would have radically decreased side effects and may even have been more effective than the CBD. According to the authors:

“Elevated levels of liver aminotransferase enzymes (alanine aminotransferase or aspartate aminotransferase level >3 times the upper limit of the normal range) led to withdrawal from the trial of three patients in the cannabidiol group and one in the placebo group.

Overall, elevated aminotransferase levels occurred in 12 patients in the cannabidiol group and one in the placebo group. All these patients were taking a form of valproate [editor’s note: a type of medication used to treat epilepsy] … There were … no instances of suicidal ideation … There were no deaths.”

As mentioned earlier, 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.”⁸

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.

Monopoly in South Dakota Avoided, for Now

As noted by Motherboard, “parents with children suffering from Dravet’s syndrome and many other serious illnesses have been pushing for access to the “miracle drug” since 2013, when Gupta’s “Weed” documentary debuted on CNN.” The program featured a 6-year-old girl beset by some 300 grand mal seizures each week. A CBD-rich cannabis oil reduced her seizures by 99 percent.

Following the airing of “Weed,” hundreds of families moved to Colorado to obtain the herbal medication for their ailing child. Other positive media attention has also helped to loosen the stigma surrounding medical marijuana. In 1969, only 12 percent of Americans favored marijuana legalization. Today, a majority of Americans favor legalization: 53 percent favor legalizing marijuana across the board and 77 percent support legal medical use.⁹ Even the new surgeon general has cited data on how helpful medical cannabis can be.

Unfortunately, medical cannabis may just 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. Still, GW Pharmaceuticals has reportedly contracted lobbyists in several different states¹⁰to fight for its cause, and their combined efforts may well delay implementation of cannabis reform that could improve access to medicinal marijuana. As noted by Melissa Mentele, chairperson of New Approach South Dakota, a cannabis reform group, who herself found relief from chronic pain when she started taking CBD-rich cannabis oil:

“Cannabis patients and caregivers have organized and fought for decades for the government to look at cannabis as a treatment option. Nobody did until hundreds of patients bravely shared their stories. So, we as a community have done the work for them, and now Big Pharma wants to swoop in and use an unfair monopoly and an inferior product to profit off the backs of catastrophically ill and dying people. It is disgusting.”

Indiana Cracks Down on CBD Products

In related news, Indiana Gov. 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 Indy Star, “Most of the CBD products being sold in Indiana contain less than 0.3 percent THC, meaning they can’t produce a ‘high,'” adding that “Advocates of CBD oil say those products don’t have as many benefits as full spectrum CBD oil products.” At present, Indiana law only allows CBD products to be used by epileptic patients, who must register with the state’s CBD oil registry.

Republican state Sen. Jim Tomes has vowed to introduce legislation that would expand access to CBD oil under state law. According to Indy Star, “He’s received calls from people who’ve used the product to treat arthritis, Parkinson’s disease and mental illnesses.” Tomes told the paper, “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 Tomes’ question appears to be drug industry pressure. As reported by New Hope:¹¹

“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 percent THC (the high-inducing cannabinoid).

The Nov. 21 advisory opinion was issued from the state capital of Indianapolis, which also happens to be the headquarters of pharmaceutical giant Eli Lilly & Co., which is seeking fast-track approval from the FDA for its non-opioid painkiller drug, tanezumab.¹²

‘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,’ Hill wrote in his opinion. This conclusion does not apply to any product that is approved by the FDA.

There are currently two products that contain cannabidiol undergoing clinical trials; Epidiolex and Sativex. Simply put, cannabidiol is a Schedule I controlled substance because marijuana (Cannabis sativa) is a Schedule I controlled substance.'”

Legal Products Confiscated Amid Confusion

There’s plenty of confusion, however, as the attorney general’s opinion and Holcomb’s seizure instructions contradict a 2014 industrial hemp law that allows CBD products in Indiana as long as they contain less than 0.3 percent THC. The primary confusion appears to center around the fact that state law permits CBD as long as it is sourced from hemp and not marijuana.

In an effort to resolve the problem, the hemp industry, led by CV Sciences, 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 in fact legal in Indiana as long as they’re sourced from hemp. All of this just goes to show that when it comes to cannabis and its derivatives, there’s plenty of confusion to go around, and it’s not always easy to determine the legal status of a given product in a given state.

FDA Issues Warning Letters to CBD Manufacturers

The FDA is also increasing its scrutiny of companies making CBD products. As reported by The Cannabist,¹³ four 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:¹⁴

“[T]he agency today issued warning letters to four 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 letters¹⁵ also 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 propensity to make illegal claims; it also raises concerns that the legality of all CBD products is in question now that CBD-containing drugs await FDA approval.

Medical Marijuana Lowers Prescription Drug Use and Abuse

While CBD has now been reclassified to a Schedule IV substance in North Dakota by excluding it from the state’s definition of marijuana,^16,¹⁷it still remains a Schedule I (illegal) controlled substance in most other states. This is tragic, considering the evidence showing medical marijuana lowers prescription drug use. One wonders if perhaps that’s one of the reasons why it hasn’t been rescheduled across the nation.

There are no other truly compelling reasons why addictive narcotics like OxyContin are legal, while marijuana – which is extremely unlikely to kill you even if you take very high amounts – is not. The video above features W. David Bradford, Ph.D., whose study was published in the journal Health Affairs in July 2016.¹⁸ As reported by The Washington Post:¹⁹

“[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.“

Legalizing Marijuana Could Save Medicare Hundreds of Millions Each Year

According to Bradford, the Medicare program could save $468 million per year if marijuana were legalized in all U.S. states.^20,²¹ Already, $165 million was saved in 2013 in the 18 states where medical marijuana was legal that year. Similarly, a 2015 working paper by The National Bureau of Economic Research (NBER) states that:²²

“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 percent drop in substance abuse admissions. So, it would seem medical marijuana – far from being the deadly drug it’s been made out to be – could actually save thousands of lives that would otherwise be destroyed by painkiller addiction and its lethal consequences.

It’s a real travesty that the U.S. Senate is more than 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 our noses.

Both CBD and THC Are Far Safer Than Commonly Used Pain Killers

Polls show older Americans are becoming increasingly converted to marijuana use.²³ Between 2006 and 2013, use among 50- to 64-year-olds rose by 60 percent. Among seniors over 65, use jumped by 250 percent.²⁴ 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 godsend.

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 against the known toxicities of many drugs currently in use. This includes liver and kidney toxicity, gastrointestinal damage, nerve damage and, of course, death.

Cannabidiol has no toxicity and it’s virtually impossible to die from marijuana. It’s also self-limiting, as excessive doses of THC will provoke anxiety, paranoia and nausea. Such side effects will disappear as the drug dissipates from your system without resulting in permanent harm, but it’ll make you think twice about taking such a high dose again. Make the same mistake with an opioid, and chances are you’ll end up in the morgue.

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 2010, the Center for Medical Cannabis Research (CMCR²⁵) released a report²⁶ 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.

Where to Find Reputable Information About Medical Cannabis, Its Uses and Benefits

While reputable information about cannabis can be hard to come by, it’s not impossible to find. One good source is cancer.gov.^27,²⁸ This is the U.S. government’s site on cancer. Simply enter “cannabis” into the search bar. You can also peruse the medical literature through PubMed,²⁹ which is a public resource (again, simply enter “cannabis” or related terms into the search bar).

CMCR also provides a hyperlinked list³⁰ of scientific publications relating to a wide variety of medicinal uses of cannabis, and the Journal of Pain,³¹ 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,³² which also has information relating to the medicinal aspects of marijuana, preclinical 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.

To learn more, I also recommend listening to my previous interviews with Gedde and Dr. Allan Frankel, in which they discuss the clinical benefits of cannabis. Frankel is a board-certified internist in California who has treated patients with medical cannabis for the past decade. Awareness is starting to shift, and many are now starting to recognize the medical value of cannabis.

Unfortunately, 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. It’s up to us to make sure we stay involved in the political process whenever marijuana-related legislation is brought up. If we don’t, you can be sure the drug industry will become the only game in town.

Sources and References