by Paul Fassa
Health Impact News
The recent 2016 DEA (Drug Enforcement Agency) decision to keep cannabis as a controlled substance Schedule I drug came amidst high hopes that it would be placed as Schedule II or below. Schedule I means the substance is dangerous, addictive, and has no medical merit.
The “subject to abuse” phrase and “no approved medical application” are pivotal talking points with the DEA’s scheduling. Substances described by those phrases are at the top of DEA’s Schedule.
Both Schedule I and II are considered dangerous and subject to abuse and addiction. Only Schedule I has no medical merit. The addictive and dangerous drug Ritalin, for example, is a Schedule II drug.
Putting kids on that variation of amphetamine with medical prescriptions is medically and culturally accepted. As are Oxycontin and other opioid painkillers listed in Schedules II and III, considered less dangerous than cannabis and with medical merit.
Marijuana or cannabis is ranked with heroin, and LSD. Heroin is an addictive and dangerous opiate that in other opioid forms such as morphine is used to suppress pain with legal prescriptions. Here’s the DEA’s summarized controlled substance list.
President Obama Disappoints Many Who had High Hopes in Him Removing the Schedule I Classification
Would these two men have achieved the success they did if they had been arrested when they were younger for using marijuana?
President Obama was once seen as a supporter of removing the federal Schedule I classification that has been used to incarcerate more young people in the United States at a percentage higher than almost any other country world-wide.
In 2013, Obama’s Justice Department said it would allow Washington state and Colorado to proceed with recreational marijuana sales. Obama said he had bigger fish to fry.
It seemed only fitting for a president who loved to smoke pot as a teen growing up in Hawaii, one who delighted pot lovers by proclaiming in 2006 that, unlike Bill Clinton, he had smoked marijuana and inhaled quite frequently. After all, he said, that was the point.
On Thursday night, though, legalization advocates had grown weary of the 44th president. They scheduled a protest to throw marijuana seeds on the White House lawn to show their dismay at the Drug Enforcement Administration’s rejection of a petition to remove marijuana from its place on the list of most dangerous drugs.
The decision quashed the hopes of legalizers who thought it would be Obama who would finally remove marijuana from the list that includes LSD and heroin.
DEA Reasoning to Refuse Cannabis Reclassification
DEA head Chuck Rosenburg’s letter to petitioners who wanted cannabis rescheduled had the following statements in italics with emphasis added to specific points that are inaccurate.
The HHS [Health and Human Services] concluded that marijuana has a high potential for abuse, has no accepted medical use in the United States, and lacks an acceptable level of safety for use even under medical supervision. Therefore, the HHS recommended that marijuana remain in Schedule I.
As detailed in the HHS evaluation, the drug’s chemistry is not known and reproducible; there are no adequate safety studies; there are no adequate and well-controlled studies proving efficacy; the drug is not accepted by qualified experts; and the scientific evidence is not widely available.
At present, there are no marijuana products approved by the U.S. Food and Drug Administration (FDA), nor is marijuana under a New Drug Application (NDA) evaluation at the FDA for any indication.
The DEA’s complete petition refusal letter can be accessed here.
The DEA and FDA Relationship
There have been 60 peer reviewed studies of plant cannabis extracts from 1990 to 2014. Most of them were from actual plant extracts, not synthetically derived active ingredients. Most of them observed favorable results. (Source)
Among them are Marinol and Cesemat, both approved by the FDA in 1985 as secondary options for reducing chemotherapy nausea and increasing appetite for both chemo and AIDS patients.
They are both synthetic versions of THC, the most condemned aspect of cannabis that promotes the marijuana high. Marinol, listed as dronabinol is a DEA Schedule III drug and Cesemat or nabilone is a DEA Schedule II drug.
The complete DEA controlled substance schedule list by alphabet is the only place where you’ll find dronabinol and nabilone listed. It can be accessed here.
Investigational New Drug (IND) applications have been accepted by the FDA from drug companies wishing to pursue research into creating synthetic CBD (cannabidiol), the other major cannabinoid of cannabis with low or no levels of THC.
The IND application is a technical precursor to the NDA (New Drug Application). A drug company must receive the IND first then the IND becomes part of the NDA, which allows the drug company to test on humans before submitting the licensing application along with a 2 million dollar plus licensing fee cited later in this article under the subtitle “The FDA Protects the Pharmaceutical Industry.”
CBD can be easily extracted from industrial hemp, which limits the THC level of 0.3 percent per dry weight of hemp. It has been highly successful at greatly reducing seizures among epileptic children, whose statistics have risen with the CDC’s increased vaccination schedules.
Along with their IND approvals to drug companies for CBD synthetic creations, the FDA has issued warnings to CBD suppliers who extract CBD from whole plant hemp, forbidding them to consider natural CBD extracts as food or supplements. It appears the FDA is protecting their pharmaceutical company clients by clamping down on natural CBD in favor of allowing drug companies to produce synthetic CBD.
Isolating active ingredients from natural herbs and plants and recreating them synthetically allows drug companies to patent their products. But without the other compounds involved in a natural source’s synergy, the synthetic versions are not as efficacious or nearly as safe. However, creating synthetic drugs allows for patents that guarantee a market monopoly for up to 20 years.
That fact that at least 100,000 people in the USA die from correctly prescribed and applied pharmaceuticals annually is an indication of this fact. Additionally, pharmaceutical use creates side effects that lead to prescribing other pharmaceuticals. This provides an excellent business model that does little to nothing for healing. (Source)
Over the past few decades, millions have been killed or permanently injured by approved pharmaceutical drugs. The lawsuit damages awarded and fines administered pharmaceutical companies are merely the cost of doing business in this lucrative endeavor misnamed medicine. (Source)
It’s been discovered empirically that cannabis users usually manage their symptoms well or actually heal and recover while dropping the pharmaceutical medications prescribed to them.
There are at least 60 other cannabinoids and several other compounds in the cannabis plant that create a balanced synergy that makes it not only efficacious, but very safe. No one has died or been disabled directly from marijuana. Health Impact News posted an earlier article that explains the real reason why the federal government wants to keep cannabis banned as medicine. (Source)
While isolating active compounds from plants to mimic synthetically allows patents that protect against competition, these laboratory creations do not carry the plant’s synergistic healing and internal safeguards that protect against side effects.
The FDA Protects the Pharmaceutical Industry
The recent DEA letter refusing cannabis rescheduling claims it defers to the FDA for deciding medical use, and the lack of medical use was the determining factor for not rescheduling cannabis, not safety issues.
But the FDA’s major paying clients are the pharmaceutical companies. They are allowed to do their own efficacy and safety studies and submit their final sometimes edited studies to the FDA for approval.
The Prescription Drug User Fee Act (PDUFA) was enacted in 1992. It provided a system for user fees to be levied on pharmaceutical companies whose products were up for licensing. As of 2014, the user fee was $2,169,100, according to a Forbes Magazine article linked below in the Sources section.
Then the pharmaceutical drug becomes licensed for market to the end of its patent period, which can be up to 20 years. That’s when generic drugs that mimic the original patented and licensed drugs are allowed to apply for licensing and compete against the originally approved drug at lower prices.
Keep in mind that the FDA does not perform safety or efficacy studies. The FDA merely reviews industry studies of their own products. And there have been many criticisms of industry studies by independent scientific groups, such as the Cochrane Collaboration and individual scientists and journalists who monitor these activities.
They have pointed out major pharmaceutical study flaws: Ghost written reports by industry hired hacks that doctors or scientists are paid to sign as their own; checkbook science where universities oblige their current and hopefully future funding sources; and the industry’s cherry picking study results to eliminate negative reports.
After enough misery and death from approved pharmaceutical drugs attracts some publicized hefty lawsuits, the FDA may demand black box warnings for those pharmaceutical products.
Black box warnings are the most severe warnings about an approved drug’s dangers that somehow only appear after some time on the market, enough time to cause damage and realize profits. Many physicians ignore them. Most consumers don’t know about them. Here’s a list of black box drugs that are still prescribed.
Then there are those revolving doors between government and pharmaceutical companies. These revolving doors are considered by some to have their influence on career ambitious agency bureaucrats who can rubber stamp pharmaceutical products and retire from government with high paying entries into pharmaceutical companies for their favorable treatment.
Occasionally the revolving door swings the other way, bringing pharmaceutical industry individuals into the FDA. Our healthcare system has become dangerous. This system is broken, and this earlier Health Impact News article explains how and why.
Fortunately, medical marijuana is allowed in half our states currently, even though some are less liberal than others. Those states are profiting financially and many in those states are getting positive results from medical marijuana.
Despite continuing oversight from Congress that protects those states’ rights for sanctioning medical marijuana, the DEA continues as the federal police force that makes using the cannabis plant a crime.
This allows pharmaceutical companies time to get FDA licensing for creating inferior and potentially dangerous synthetic versions of that same plant’s isolated compounds because the FDA refuses to allow cannabis or hemp plants to be considered medicine or food.
Hypocrisy? You or Your Doctor Cannot Legally Purchase Marijuana, but Soon Drug Companies Will because of “Medical Research Value”
In what appears as an obvious hypocritical move that benefits only Big Pharma, the DEA, while not removing the criminal legal status on marijuana, did relax the laws regarding research on marijuana which will soon benefit drug companies looking to patent drugs that mimic what the plant already does. The official statement from the DEA states:
To facilitate research involving marijuana and its chemical constituents, DEA is adopting a new policy that is designed to increase the number of entities registered under the Controlled Substances Act (CSA) to grow (manufacture) marijuana to supply legitimate researchers in the United States. This policy statement explains how DEA will evaluate applications for such registration consistent with the CSA and the obligations of the United States under the applicable international drug control treaty.
“Legitimate researchers” will obviously be the few pharmaceutical companies that fund the FDA and are allowed to patent drugs in the United States.
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