DEA Officially Declares Synthetic THC More Medicinal than Whole Plant Cannabis

by Paul Fassa
Health Impact News

The pharmaceutical industry is pulling out the stops lobbying government officials and influencing those that are inclined toward prohibition, to protect not only their synthetic THC interests but also their vast exclusive pharmaceutical market.

Increased cannabis use is intruding on the pharmaceutical industry’s turf.

It has been implied and most of us could see it coming, but on November 22, 2017, it became official. The DEA placed synthetic THC, Dronabinol, the medicinally powerful compound that creates the high in marijuana, as a Schedule II controlled substance, yet whole plant cannabis remains as a Schedule I controlled substance.

This final ruling closed the door on public comments invited for the DEA’s initial interim ruling.

Here is a pdf copy of the DEA announcement document filed in the Federal Registry.

The DEA ensured in writing that dronabinol is Schedule II if only as part of a DEA approved drug. If not the active part of an FDA approved pharmaceutical drug it is listed as Schedule I along with whole plant cannabis.

Just in time for Insy Therapeutics to enjoy their exclusive marketing position with Syndros, a dronabinol spray liquid and delivery system recently approved for marketing by the FDA. This product is novel with its delivery as a spray, but the stated results are the same as Marinol or dronabinol in general. From the Insy webpage:

Syndros is approved for use in treating anorexia associated with weight loss in patients with Acquired Immune Deficiency Syndrome (“AIDS”) and nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. (Source)

Dronabinol is a synthetically derived mimicry of THC. It is not an extract from the cannabis plant. Even if it were, isolating a compound from natural sources is usually not the best way to go. All the balancing compounds should be available. This totally synthetic chemical is compounded after a long chemical process, which is explained in this earlier patent submission.

Compared to whole plant cannabis products, this is a very minuscule list of purported benefits. And they conveniently don’t interfere with the pharmaceuticals that are the big money makers, such as the arsenal of chemo products for cancer patients and long list of drugs for “HIV” AIDS. Dronabinol products only attempt to compensate for the side effects of pharmaceutical drugs used for cancer and AIDS.

Many who use whole plant cannabis medically for cancer are successful with natural cannabis compounds directly. And there are no serious side effects as there are with synthetic versions of THC. Those who use whole plant cannabis for cancer often are able to avoid chemo and radiation.

Those who used cannabis to heal from Crohn’s or colitis, and other serious diseases were able to wean themselves away from the large amount of pharmaceuticals they had been on. Those who used cannabis exclusively to heal also avoided hospitalization and even escaped from hospice alive and well. (Source)

Schedules Summarized

Schedule I controlled substances (drugs) are considered to have “no currently accepted medical use in the United States, a lack of accepted safety for use under medical supervision, and a high potential for abuse.”

The phrase “no accepted medical use…” means it is not an FDA approved drug. That’s all it means. Schedule I drugs include drugs such as heroin.

Schedule II drugs also “have a high potential for abuse which may lead to severe psychological or physical dependence.” But they can be prescribed by doctors because they are pharmaceutical drugs approved by the FDA: Oxycontin, morphine, Ritalin, and others. There are other opioids in addition to Oxycontin listed as Schedule II.

Cannabis has been used successfully to get opioid pain killer and heroin addicts off those drugs safely and permanently. One danger of opioids is their effectiveness diminishes over time, making them useless until the dosage is increased again and again, leading to a final lethal overdose. (Source)

Cannabis handles chronic pain safely without the need for increasing the dose, which if increased would not result in death. Cannabis is not physiologically addictive, though like anything else considered pleasurable, like eating ice cream or watching sports on TV, it can become psychologically addictive.

Many who cure themselves of terminal diseases maintain a lowered cannabis dose as a preventative, without harm.

There are three other broad classification schedules, all diminishing in danger of dependency and abuse as the numbers reach V (five). They are all pharmaceutical drugs approved by the FDA.

But only Schedule I drugs are “without medical merit” or unapproved by the FDA. Somehow this warrants arresting anyone who uses a Schedule I drug of any kind for any purpose. (Source)

Obvious Ironies

The most basic irony is the idea of synthetically creating one compound of a natural plant and making it legal for medical applications while banning the plant from which it was copied synthetically, even making its use illegal.  Unfortunately, this is business as usual with the pharmaceutical industry.

Much of what is passed as medicine is made that way, usually while vilifying or marginalizing the natural source from which a compound was synthetically copied.

Medicinal plants are composed of several compounds that balance out potential toxins while creating a synergistic preventative or curative dynamic. For example, THC is only one of two dominant cannabinoids known for their medicinal properties. The other is CBD or cannabidiol, which is not psychoactive at all. It does have some medicinal properties and helps dampen THC’s psychoactive effects.

CBD is either extracted from cannabis or taken from plants bred to be very low in THC and high in CBD. Some brands of CBD oils or tinctures are from industrial hemp, which is closely related to cannabis but hybrid naturally to be extremely low in THC.

To patent CBD or cannabidiol, the CBD molecule has to be created synthetically and not extracted directly from the plant, which would allow only the extraction process to be patented.

Synthetic CBDs can be registered for exclusive marketing for a period of up to 20 years with FDA approval and a brand name at a higher price than any natural CBD would go for.

Do you see how the alliance of Big Pharma, the FDA, and the DEA protects the pharmaceutical industry while denying natural medicines? More on this here.

After those two most dominant cannabinoids, THC and CBD, there are perhaps 80 others. The cannabis whole plant also contains many other health providing compounds. Terpenes are what give cannabis, and other flowers and fruits, their scent and taste. But more importantly, additional medicinal benefits.

Flavanoids are found in many plant foods and are phytonutrients that are often antioxidant and protective against major diseases.

A synthetic isolate from cannabis or any other plant source of medicine excludes all other phytonutrients and compounds that are naturally balanced to usually not provide adverse side effects.

This is why synthetic drugs have to be safety tested. They have no history of safety because they are novel and never used by any culture at any time in history, unlike herbs and other traditional medicinal plants.

Cannabis is also an herb, and there is not one incident of death recorded from cannabis intake, smoked or orally ingested, in any form. Meanwhile, several deaths and serious adverse events occur from FDA approved drugs correctly prescribed and properly taken, annually.

There are even more dead bodies from opioid pain killers because patients become addicted, the pains persist, and the drugs’ effectiveness wanes, leading to higher doses and death by asphyxiation. Opioid and heroine overdosing inhibit the breathing mechanism.

The whole plant effect from all the cannabinoids, terpenes, and flavanoids creates what’s called an “entourage effect” that creates a vast healing synergy without harmful side effects to cover a wide range of illnesses, some which are considered incurable by mainstream medicine.

This entourage effect remains to be explored more as various breeding techniques can adjust them naturally and fine tune them according to individuals and their ailments.

Pharmaceutical Safety Testing Continues in the Market Place

Pharmaceutical drug trials are lengthy and expensive. Often companies with adequate capital to fund studies are competing with other companies in pursuit of FDA approval and the license to market. The drug companies pay a fee to the FDA, usually around 2 million dollars.

Since the drug companies provide the FDA with their trial documents for review toward approvals, shortcuts and editing out negative test trials are rampant. And the FDA looks the other way while collecting their 2 million dollar licensing fees from the pharmaceutical companies. (Source)

Here are some examples of trial misconduct that are common:

• Cherry picking trial reports to include only the two most favorable required by the FDA
• Excluding trial reports that are negative
• Checkbook research, where research groups allow the result desired to lead their research
• Simply cheating with the items used in a study
• Ghost writing by hired copywriters signed by prestigious doctors paid for their signatures to publish in medical journals
• Statistical manipulation and subterfuge

Many think the necessity of expensive lengthy drug trials is to protect consumers and let doctors know of the latest most efficacious medicine they should prescribe. Consider what former FDA commissioner Dr. Herbert Leonard Ley Jr. told the NY Times in December 1969 after his resignation.

“The thing that bugs me is that the people think the FDA is protecting them – it isn’t. What the FDA is doing and what the public thinks it’s doing are as different as night and day.” (Source)

That’s why so many adverse events and deaths from FDA approved and newly released drugs occur over time. The class action suits demonstrate this. After years of high profits, settling lawsuits can easily overcome costs of business, the FDA may issue black box warnings of potentially serious adverse events.

But unless the body count is overtly epidemic, the drug remains on the market until the pharmaceutical company decides class action lawsuits and bad publicity are eroding their bottom line.

A famous example was Merck’s NSAID pain killer Vioxx, which was removed from the market after an estimated 60,000 deaths from heart attacks while using it. In the meantime, Merck made billions in sales.

Part of the problem was sourced to ghost written articles posted in medical journals that promoted Vioxx as safe and effective for even off-label use, signed by prominent physicians who knew nothing of what the articles were about, for significant fees. (Source)

How Does Dronabinol Fare With Side Effects?

Known side effects from dronabinol (Marinol) or Syndros categorized as a Schedule II controlled substance, (my comments in parenthesis):

• Seizure (convulsions) (Yet whole plant cannabis products have eliminated seizures among incurable epilepsy victims including children.)
• Paranoia, extreme fear
• Fast heart rate
• Feeling light-headed, fainting
• Unusual thoughts or behavior
• Mood changes
• Dizziness, trouble concentrating
• Feeling “high”
• Weakness, lack of coordination
• Anxiety, confusion
• Stomach pain, nausea, vomiting, diarrhea (Yet whole plant cannabis oils have cured Crohn’s and IBS victims.)
• Warmth or tingly feeling
• Sleep problems (insomnia) (Source)

Of course, there is not much history with dronabinol or the trade name versions Marinol and Syndros. Eventually, more side effects may occur long term.

Who knows what wasn’t included in the Marinol trials. The unofficial track record of medical cannabis compared to pharmaceutical medicines is upside down. There is no comparison.

If there were no restrictions on cannabis anywhere, and if doctors would escape the pharmaceutical and medical boards’ matrix to get educated on cannabis as a primary medicine, the pharmaceutical industry would almost go out of business and have less influence over the medical professions.

Then we would have a healthier population with less iatrogenic deaths, (early deaths from diseases).