Big Pharma Tries to Monopolize CBD Oil Market by Dr. Mercola
Big Pharma Tries to Monopolize CBD Oil Market
December 11, 2017 • 139,899views
Story at-a-glance
The
cannabinoids in cannabis — cannabidiol (CBD) and tetrahydrocannabinol
(THC) — work by way of naturally-occurring cannabinoid receptors
embedded in cell membranes throughout your body
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
South Dakota has rescheduled CBD from a Schedule I to a Schedule IV substance by excluding it from the definition of marijuana
GW
Pharmaceuticals failed in its efforts to restrict Schedule IV
classification to FDA approved CBD products only, which prevented the
company from creating a monopoly in South Dakota
The
legal status of CBD oil as a nutritional supplement is now threatened by
drug companies seeking FDA approval for CBD-containing drugs
By Dr. Mercola
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.6
The 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 studydocumented 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 states10
to 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,16,17
it 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.
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