After it waged a veritable war against cannabis legalization in Arizona, coughing up half a million dollars for the campaign, pharmaceutical company Insys Therapeutics recently announced its ultimate victory has finally come to fruition: the DEA has approved one of the company’s groundbreaking pharmaceuticals — synthetic marijuana — to be listed as a Schedule II substance.
“Insys gave $500,000 last summer to Arizonans for Responsible Drug Policy, the group opposing marijuana legalization in Arizona,” the Washington Post reported. “The donation amounted to roughly 10 percent of all money raised by the group in an ultimately successful campaign against legalization.Insys was the only pharmaceutical company known to be giving money to oppose legalization last year, according to a Washington Post analysis of campaign finance records.”
That flood of cash from the pharmaceutical company with a vested interest in killing legalization probably did just that.
Now, the equally profit-motivated U.S. government has bestowed on Insys Therapeutics what is tantamount to skirting federal cannabis prohibition — despite that synthetic Syndros contains the equivalent ingredient, THC, which nature provided in the first place.
This coordinated effort between a profiteering, private entity and the U.S. government to not only crush, but scoff at our personal liberties sounds a quiet but resounding alarm for America’s legal cannabis industry.
The fact the cannabis plant, itself still languishes as a supposedly dangerous Schedule I substance, while Big Pharma can profit from its imitation, did not occur by happenstance — in fact, Insys’ history should have flatly nullified this government-granted windfall.
Syndros garnered approval from the U.S. Food and Drug Administration last summer for the treatment of the nausea, vomiting, and weight loss suffered by AIDS and cancer patients.
Now, Insys has received the green light from the Drug Enforcement Agency, which categorized the synthetic substance and its generic formulations as Schedule II — a classification placing it alongside substances from cocaine and methamphetamines, to Adderall, OxyContin, and even methadone.
Cannabis remains on the DEA’s hitlist of Schedule I dangerous substances the State vilipends as devoid of redeeming medical value, on par with heroin, LSD, ecstasy, and peyote — largely due to pressure from, if not surreptitious coordination with, Big Pharma. See: Report Shows DEA Deliberately Blocked Beneficial Science to Perpetuate War on Cannabis
Insys’ brash endeavor to crush cannabis legalization while attempting approval of a fabricated concoction that mimics the vilified plant must be the most astonishingly callous example of corporate profiteering we’ve seen in years — and indeed, this hypocrisy has not escaped the cannabis advocacy microscope.
“It appears they are trying to kill a non-pharmaceutical market for marijuana in order to line their own pockets,” J.P. Holyoak, chairman of the Campaign to Regulate Marijuana Like Alcohol in Arizona, asserted last year.
Even a cursory examination of Insys Therapeutics’ anti-pot propaganda — imbued with all the patronizing semantics characteristic of an industry too experienced in cozying up to the U.S. government — belies the inanity in Big Pharma’s naked profiteering.
In short, it doesn’t matter to Insys and the federal government that scores of patients suffering a startlingly wide spectrum of ailments find relief from a plant, cannabis, in its natural state — together with loosening laws nationwide — cannot profit Insys.
But a fabricated version of the plant — and its oh-so-helpful categorization as less dangerous than what nature managed to produce — can.
During its shameless anti-pot campaign, Insys bloviated of legalization, “it fails to protect the safety of Arizona’s citizens, and particularly its children.”
Perhaps targeting the heartstrings of family members whose loved ones use cannabis to treat childhood epilepsy and seizures, cancer, post-traumatic stress disorder (PTSD), Crohn’s disease, addiction, depression, ADHD, or one of myriad other conditions, Insys deigned itself a shield between customers and the villain plant, adding:
“[Insys] firmly believes in the potential clinical benefits of cannabinoids… [and] we hope that patients will have the opportunity to benefit from these potential products once clinical trials demonstrate their safe and effective use.”
That socially-awkward attempt to seem compassionate fools no one — and hasn’t yet — considering Insys Therapeutics began seeking the boundless profits of synthesized cannabis more than a decade ago.
Insys predicted current staggering support for the medical and recreational use of cannabis years ago, as the company postured on the need to maintain the non-synthetic plant’s Schedule I status in a 2011 letter to the DEA, noting:
“[The] longstanding policy of the United States to disfavor domestic cultivation of narcotic raw materials because of concerns about the abuse potential from farming of this material.”
But evidence that the pharmaceutical company’s hostility toward the cannabis plant pertained to the profits deprived it, in actuality, came years earlier — Insys’ own words from nearly a decade ago substantiate fully the financial motivation. A disclosure filed by Insys on August 17, 2007, with the Securities and Exchange Commission (SEC) proves beyond a doubt that the profit-robbing factor motivated the killing of cannabis legalization. Forgoing pretense, Insys asserted:
“If marijuana or non-synthetic cannabinoids were legalized in the United States, the market for dronabinol [Syndros] productsales would likely be significantly reduced and our ability to generate revenue and our business prospects would be materially adversely affected.”
Of course, given Insys Therapeutics’ penchant for flying fast and loose with the law when profits are at stake aligns perfectly with the company’s insultingly-hypocritical, patently-fictitious moralizing on public health concerns.
Insys is now under investigation for off-brand marketing of fentanyl — an opioid painkiller 50 times stronger than Schedule I-listed heroin, and one of the most addictive substances available — a route pharmaceutical companies take when a drug is either found efficacious in treating an additional condition, or when sales for the approved purpose slump.
Worse, and lending further credence to the company’s profit-no-matter-the-cost modus operandi, several Insys executives were just arrested in December for conspiring to pay off healthcare workers to recklessly prescribe the medication — even when the dangerous opioid wasn’t needed. According to the U.S. Attorney for the District of Massachusetts in an announcement on December 8, 2016:
“Several pharmaceutical executives and managers, formerly employed by Insys Therapeutics, Inc., were arrested today on charges that they led a nationwide conspiracy to bribe medical practitioners to unnecessarily prescribe a fentanyl-based pain medication and defraud healthcare insurers.”
Stated Harold H. Shaw, Special Agent in Charge of the Boston Field Division of the FBI, after the arrests:
“As alleged, top executives of Insys Therapeutics, Inc. paid kickbacks and committed fraud to sell a highly potent and addictive opioid that can lead to abuse and life threatening respiratory depression. In doing so, they contributed to the growing opioid epidemic and placed profit before patient safety. These indictments reflect the steadfast commitment of the FBI and our law enforcement partners to confront the opioid epidemic impacting our communities, while bringing to justice those who seek to profit from fraud or other criminal acts.”
Yet, the duplicitous nature of the U.S. government’s prohibition on cannabis now has the DEA, putatively Drug Warrior Number One, transparently forking over legal protections for synthetic THC, allowing the company to profit handily, while the plant’s scheduling makes criminals out of patients legitimately using cannabis for medical reasons.
It is this skirting of legality, deceptive marketing, duplicitous propaganda, offensively direct assistance from the government, and flagrant criminality that make Insys Therapeutics the exact corporate thug paragon of a monied-interest, authoritarian Police State.
If you need a case to abolish the State, look no further than its dealings with the cannabis plant — whether or not you are a user, the miraculously beneficial weed has flourished for centuries unmolested by self-important empires, until fiat currency made it a threat to unscrupulous profiteers.
The State’s farcical war on cannabis has effectively ended for most Americans — and it’s well overdue the government catch up with the rest of us.
The U.S. spends more than $51 billion annually on the war on drugs. In 2014, more than 1.5 million arrests for drug-related violations were made, 83 percent of which were for possession only
No real effort is put into minimizing the availability of opioids. Perhaps worst of all, no consideration is given to alternatives that are FAR safer and just as effective; marijuana being one of them
The DEA recently announced its intent to move the herb kratom into a Schedule I controlled substance. Many use the herb to wean off opioids and relieve pain in lieu of these potent and addictive drugs.
Drug addiction has reached unprecedented levels in the United States. Each year, the U.S. spends more than $51 billion on the war on drugs and, in 2014, more than 1.5 million arrests for drug-related violations were made.1 Of those arrests, 83 percent were for possession only.
The vast majority of drug-related arrests are for marijuana, and 88 percent of those are for possession only. Amazingly, 1 in every 111 adults in the U.S. is incarcerated (the highest incarceration rate in the world).
While nearly half of all U.S. states now allow the medical use of marijuana,2 and 20 have decriminalized marijuana possession and use, the federal government still classifies marijuana as a Schedule 1 controlled substance3,4 — a category reserved for the most addictive and dangerous of drugs, including heroin and LSD.
According to the 1970 Controlled Substances Act, Schedule 1 drugs are defined as those having a “high potential for abuse” and “no acceptable medical use in treatment.”
Yet the Department of Health and Human Services (HHS) has held a patent for marijuana as a “neural protectant,” claiming it can protect your brain against stroke and trauma, since 2003.5
The War on Drugs Is an Utter Failure
The illogical and hypocritical stance on marijuana is but one way the U.S. Drug Enforcement Agency () does more harm than good.
Considering the vast majority of drug-related arrests and convictions are for cannabis possession and use, the DEA is acting as a “head hunter” to fill up privately owned prisons with non-violent ganja users, who may or may not be using it for valid medicinal purposes.
Whether used for medical purposes or recreation, marijuana is nowhere near as dangerous as opioids, and addiction to prescription painkillers is spiraling out of control in this country. Yet when it comes to these profitable drugs, the DEA suddenly takes a whole different view on drug addiction.
Speaking about the heroin epidemic at a meeting in Cleveland, Ohio, (see video above) DEA chief Chuck Rosenberg stated we cannot “prosecute or enforce our way out of this mess.” Instead, we need to “do a much better job of getting the word out about how dangerous this stuff is.”
DEA Is Biased in Its War On Drugs
So in Rosenberg’s (and the DEA’s) view, marijuana users are criminals whom they have no qualms about prosecuting and jailing, but when a person is abusing opioid painkillers — from which drug companies profit handsomely — the answer is not criminalization but education. As reported by Cleveland.com:6
“Rosenberg was in Cleveland as his agency is working in tandem with the U.S. Justice Department in launching a multi-faceted effort in treating the overdose epidemic by partnering with local hospitals, rehabilitation clinics and educators to try and inform the public about cutting down on the use of prescription painkillers.
Rosenberg said the agency is also urging doctors across the country to cut down on prescribing unnecessary painkillers to patients, who sometimes end up addicted to the drugs or turn to more dangerous forms of opioids, such as heroin, once their prescriptions end.”
I do not support criminalizing opioid addiction, but it is hypocritical in the extreme to fill for-profit jail cells with marijuana users while saying the same “cannot” work for prescription drug addicts. As noted by Opensecrets.org:7
“The revenue from waging the war on drugs has become a significant source of financial support for local law enforcement.
Federal and state funding of the drug war — as well as the property police forces seize as a part of drug raids — have become significant financial supplements to local forces’ budgets …
One of the largest for-profit prison companies, Corrections Corporation of America [CCA], even stated in a regulatory filing that keeping the drug war alive is essential to its success as a business …”
Why DEA Won’t Go After Corporate Drug Pushers
It’s blatantly clear that the DEA does not want to criminalize prescription drug abuse because that would sorely hamper drug companies’ ability to promote and sell painkillers. And that’s really where the parties responsible for the current epidemic of addiction can be found.
Is it any surprise then that, in April 2016, a law was passed that restricts the DEA’s ability to track and charge pharmacies and wholesalers who are expanding the epidemic? Andre Kolodny, director of Physicians for Responsible Opioid Prescribing, and an addiction specialist, responded to this news saying:8
“I’m shocked that Congress and the president would constrain DEA from taking on corporate drug dealers in the midst of the worst addiction epidemic in U.S. history. This law allows opioid distributors to reap enormous profits and operate with impunity at the public’s expense.”
Many patients are shocked and surprised to find themselves hooked on opioids after filling a prescription for something simple as a wisdom tooth extraction, sports injury or bout of back pain.
They were not properly warned and educated on how to safely take these drugs, and that stems from drug companies’ deceptive marketing campaigns.
Once their prescription runs out, or can no longer satisfy their habit of use, many end up turning to heroin dealers. It’s cheaper, and works just the same. The video above is just one example of how painkillers end up feeding a longstanding cycle of addiction.9
In August, Cuyahoga County in Ohio had 52 opioid-related deaths. So far this year, the county has recorded more than 500 overdose deaths — more than double that of 2015. Many of these deaths are attributed to street heroin cut with the drug carfentanil, a sedative for large animals like elephants.
Carfentanil is anywhere from 2,500 to 5,000 times more potent than heroin. The drug is so potent it even poses a lethal risk to first responders, should they inhale or absorb a tiny amount while working on the overdose victim. The following graph illustrates opioid overdose deaths by state.
Tech Competition to Combat Heroin Overdoses
In related news, the U.S. Food and Drug Administration recently launched “The 2016 Naloxone App Competition.”10 The idea is to create a smartphone app to combat opioid overdoses. Tech wizards have until November 7, 2016, to submit their apps. As explained by CNN:11
“The FDA envisions an app that will connect anyone experiencing an opioid overdose with the closest supply of naloxone, a reversal drug.
Naloxone counteracts the effects of heroin, some addictive painkillers and the synthetic opioid fentanyl and is available at pharmacies with a prescription. It is often carried by medical and law enforcement first responders in most states as well as at-risk opioid users and family members. The app is intended to alert these antidote carriers when someone overdoses …
‘With a dramatic increase in the number of opioid overdose deaths in the US, there’s a vital need to harness the power of new technologies to quickly and effectively link individuals experiencing an overdose … with someone who carries and can administer the life-saving medication,’ FDA Commissioner Dr. Robert Califf said in the announcement.”
Again, while the thought is good, the FDA, like the DEA, is missing the mark by ignoring the SOURCE of the problem, which is prescription opioids. Gently asking doctors to ease up on prescriptions is not enough. We don’t need to incarcerate opioid addicts any more than we need to incarcerate marijuana users, but we do need to hold drug companies legally responsible for their products and the deceptive marketing practices that allowed this epidemic to swell out of control.
Opioid Epidemic Is an Undeclared Public Health Emergency
As noted in a recent STAT News article,12 the opioid epidemic really should be declared a public health emergency in order to mobilize the needed resources to address the situation.
“Congress took a first step toward responding to this expanding epidemic by passing, nearly unanimously, the Comprehensive Addiction and Recovery Act13 this summer. This $181 million act was designed to fund a wide range of activities essential to turning the tide on opioid addiction, including expansion of overdose reversal, recovery and prevention programs …
But since the Comprehensive Addiction and Recovery Act became the law of the land, Congress hasn’t made any money available to turn it into real treatments for real people. Lawmakers looked good by approving the act, but … they never appropriated the money to fund it, rendering the bill and its good intentions effectively useless.”
State of the Union
So what do we have here? We have a DEA that criminalizes marijuana — an effective and safe alternative to addictive and deadly opioid painkillers — and has repeatedly obstructed marijuana rescheduling efforts,14 thereby assuring the continued profitability of law enforcement and private prisons.15
Also, while Rosenberg has stated that “no drug product made from marijuana has yet been shown to be safe and effective,” going so far as to refer to the concept of medical marijuana as “a joke,” two synthetic tetrahydrocannabinols (THC) medicines — Marinol and Cesamer — recently received FDA approval for sale as patented drugs.
THC is a subclass of cannabinoids, the general category of active chemical compounds found in marijuana. Cannabidiols (CBD) is another subclass.16 Some cannabinoids are psychoactive, whereas others are not. THC is the most psychoactive, the one that produces the “high” associated with smoking pot.
Cannabinoids produce biological effects because, just like opiates interacting with your opiate receptors, cannabinoids interact with specific receptors located in your cell membranes. The approval of these drugs alone should be sufficient to prove marijuana has medical applications.
We have a Congress that supports the epidemic by legally restricting the DEA’s ability to pursue corporate drug dealers. Moreover, former DEA chief Michele Leonhart 17 was harshly criticized for opposing the legalization of marijuana — so much so, President Obama was petitioned18 to have her removed for her anti-marijuana stance. Yet her replacement, Rosenberg, is following in the exact same footsteps!19
We have the FDA searching for high-tech solutions to get the overdose-reversal drug Narcan20 (naloxone) into the hands of drug addicts while approving more addictive painkillers. In 2013, the FDA issued a strong warning against the use of opioids to control pain. On the very same day, the agency approved Zohydro, a drug that has five to 10 times the potential for abuse. Two years later, the FDA approved the use of opioids in children as young as 11!21
Of course, on both ends of the epidemic, we have drug companies cashing in. In 2012, $9.38 billion worth of painkillers were sold in the U.S. OxyContin alone accounted for $2.81 billion in sales.22 Meanwhile, that same year, Amphastar Pharmaceuticals (the sole maker of the nasal-spray Narcan), began what appears to be a clear case of price gouging, raising its prices by as much as 100 percent.
Protecting Opioid Profits by Banning Herbal Alternatives
It appears no serious efforts are really being made on the behalf of the federal government to crack down on deceptive and manipulative drug company marketing. No real effort is put into minimizing the availability of opioids. Perhaps worst of all, no consideration is given to alternatives that are FAR safer and just as effective; marijuana being one of them.
Were marijuana decriminalized nationwide, the drug industry clearly would take a big hit. Not only would people have access to a far less expensive, more effective and natural version of synthetic THC drugs selling at a premium, many would also turn to marijuana to relieve their aches, pains, nausea, sleep problems, anxiety, depression and even cancer instead of using opioids and other expensive and potentially dangerous drugs.
No wonder drug companies are fighting to shut down the legalization of marijuana in order to maintain their drug monopoly. What’s reprehensible is that the U.S. government is siding with the drug industry rather than doing what is best for the public health.
DEA Criminalizes Pain Relieving Herbal Tea
Besides marijuana, the DEA recently cracked down on the herb kratom, which is related to the coffee plant. The herb has garnered a loyal underground following of people using it to wean off opioids and relieve pain in lieu of these potent and addictive drugs. In late August, the DEA announced a plan to place kratom into a Schedule I controlled substance category, the same category as marijuana. Kratom users are incensed, and for good reason. As reported by Kaiser Health News:23
“In a YouTube video, a veteran shakes a bottle he says contains prescription opioids he has been given for pain. ‘This,’ he says, ‘is not Schedule I.’ ‘Do I seem angry?’ he continues, ‘Yes. Because you’re taking away a right that I fought for.
When I did my tour in Iraq, I fought for my right to be in America and be able to help myself, to cure myself. I’m not talking about snorting cocaine, shooting up heroin, I’m not even talking about puffing a joint. I’m talking about brewing some tea leaves, having a sip and feeling better’ … People have uploaded hundreds of videos talking about why they drink or swallow kratom pills — veterans coping with PTSD, recovering alcoholics [and] people with fibromyalgia.”
A WhiteHouse.gov petition24 to maintain kratom’s legal status has nearly 137,000 signatures as of this writing. The DEA has also received an “unexpected” number of phone calls from people opposing the Schedule I classification. According to DEA spokesman Melving Patterson, the reason for the strict classification is “concern for public safety,” as 660 calls to poison control centers involving kratom were received between January 2010 and December 2015.
Fifteen deaths between 2014 and 2016 have also been attributed to kratom (although kratom defenders are quick to point out that these deaths were the result of mixing the herb with other drugs).25 The DEA’s justification is about as illogical as it gets. About 14,000 Americans died from overdosing on prescription opioids in 2014.26 Yet agencies like the DEA, FDA and HHS are fighting against marijuana and kratom!
How can seven or eight deaths a year compare to the tragedy of losing 14,000? While every death is tragic, when you’re talking about public health, wouldn’t it make sense to opt for the lesser evil or, in this case, the substance that causes the LEAST amount of harm? The hypocritical nature of this state of affairs is a clear sign that these federal agencies have ceased working for the public good.
The classification is also frustrating to researchers who believe, from initial testing prior to the ruling by the DEA, that kratom may hold the key to a non-addictive painkiller or even a route for treating addiction. They found the ingredients activated just the pain relief receptors and not the secondary receptors responsible for the deadly side effects from opioids, such as respiratory depression.27
Although also addictive in nature, kratom effectively treats withdrawal symptoms from heroin without life-threatening side effects, and has been useful in treating chronic pain without the potentially lethal effects of opioid overdoses.28 Side effects include headache and nausea.29
The Making of a Blockbuster Drug
Use of the opioid prescription painkiller OxyContin has been a primary driving force behind the addiction epidemic.30 The maker of OxyContin, Purdue Pharmaceuticals, manufactured the demand for the drug, and the epidemic, by falsely claiming the risk of addiction was “extremely small,”31 and/or had less potential for abuse compared to short-acting opioids.
Both claims are false. In a recent STAT News report,32 David Armstrong also reveals the role the global healthcare company Abbott Laboratories played in creating a demand for this dangerous drug.
“The pharmaceutical sales representatives from … Abbott Laboratories had a problem,” Armstrong writes. “No matter what they tried, they couldn’t get the attention of an orthopedic surgeon to convince him to prescribe the potent painkiller OxyContin … That is, until the staff let them in on a secret: ‘We were told by his nurses and office staff that the best way to capture his attention and develop our relationship was through junk food,’ the sales reps wrote in an internal memo.
The next week, one of the Abbott representatives showed up with a sheet cake box filled with doughnuts and snack cakes arranged to spell out the word ‘OxyContin.’ The gambit worked.
The surgeon listened to the sales talk, and every week after that, the Abbott sales personnel visited the doctor to ask him to switch at least three patients to OxyContin from other painkillers. The doughnut ploy, highlighted in a trove of internal documents obtained by STAT, shows the lengths to which Abbott went to hook in doctors and make OxyContin a billion-dollar blockbuster …
Purdue Pharma LP, the Connecticut company that developed OxyContin, has been vilified for planting the seeds of today’s opioid crisis … But the role of Abbott in pushing the drug has largely escaped notice. The documents reveal it was a crucial partner in the aggressive — and misleading — selling of OxyContin during its first decade on the market.“
Doctors Are Easily and Often Manipulated
The documents, which were part of a legal case brought by West Virginia against Purdue and Abbott for the inappropriate marketing of OxyContin, reveal Abbott’s drug representatives were clearly instructed to downplay the risk of addiction. They were also taught to make other claims “that had no scientific basis,” Armstrong writes.
Purdue even agreed to indemnify Abbott from any legal expenses associated with its efforts to sell the drug — that’s how important a role Abbott Labs played in Purdue’s scheme.
Aside from the occasional doughnut ploy — which actually won the Abbot sales rep in question the “best OxyContin sales success story” award — Abbott’s drug reps also used techniques such as taking doctors to their favorite takeout restaurant or bookstore, where they would “detail” the doctor — i.e., present the selling points of the drug — while waiting to pay.
Bringing lunches, cookies or snacks are also common strategies aimed at getting on the good side of doctors, nurses and other personnel that might influence a doctor’s prescription habits. Then there were the business strategies aimed at the sales force itself. Armstrong writes:
“Abbott heavily incentivized its sales staff to push OxyContin, offering $20,000 cash prizes and luxury vacations to top performers.
Their almost religious zeal to sell the drug is evident in the wide use of terminology from the Middle Ages Crusades: Sales reps were called ‘royal crusaders’ and ‘knights’ in internal documents, and they were supervised by the ‘Royal Court of OxyContin’ — executives referred to in memos as the ‘Wizard of OxyContin,’ ‘Supreme Sovereign of Pain Management’ and the ‘Empress of Analgesia.'”
The head of pain care sales, Jerry Eichhorn, was the ‘King of Pain’ and signed memos simply as ‘King.’ ‘As you continue to carry the OxyContin banner onto the field of battle, it’s important to keep highlighting OxyContin benefits to your doctors,’ Abbott urged its sales staff in a memo contained in the court records.'”
Treating Pain Without Drugs
Considering the risks, I would urge you to consider other options before resorting to an opioid painkiller. It’s especially important to avoid opioids when trying to address long-term chronic pain, as your body builds a tolerance to the drug. Over time, you’ll require greater doses at more frequent intervals to achieve the same pain relief, which is a recipe for disaster and could have lethal consequences.
United States’ Drug Enforcement Administration (DEA) on Wednesday set new cannabis extract laws by amending the Schedule I Controlled Substances Act to include tighter regulations for marijuana extracts, including cannabidiol (CBD).
In the new drug code titled “Establishment of a New Drug Code for Marihuana Extract,” the DEA says it is “creating a separate code number for marihuana extract with the following definition: ‘Meaning an extract containing one or more cannabinoids that has been derived from any plant of the genus Cannabis, other than the separated resin (whether crude or purified) obtained from the plant.’ Extracts of marihuana will continue to be treated as Schedule I controlled substances.”
This means CBD and all other extracts derived from the cannabis plant (psychoactive or not) will come under Schedule 1 drugs, like heroin, LSD, marijuana, and ecstasy, and cannot cross state lines. Any person currently licensed to produce and handle marijuana extracts is required to apply for a modification of their registration by Jan. 13, 2017, the new document says.
A variety of medicinal marijuana buds in jars are pictured at Los Angeles Patients & Caregivers Group dispensary in West Hollywood, California, Oct. 18, 2016.Photo: REUTERS/Mario Anzuoni/File Photo
“For practical purposes, all extracts that contain CBD will also contain at least small amounts of other cannabinoids. However, if it were possible to produce from the cannabis plant an extract that contained only CBD and no other cannabinoids, such an extract would fall within the new drug code,” the DEA said.
The declaration, which critics say was made silently to avoid criticism, was justified with the help of international treaties: “Under international drug control treaties administered by the United Nations, some differences exist between the regulatory controls pertaining to marihuana extract versus those for marihuana and tetrahydrocannabinols.”
“The DEA has previously established separate code numbers for marihuana and for tetrahydrocannabinols, but not for marihuana extract,” the document’s summary read.
Medicinal marijuana activists, however, are questioning the legality of the move.
“This action is beyond the DEA’s authority,” Robert Hoban, a Colorado cannabis attorney and adjunct professor of law at the University of Denver, told Leafly. “The DEA can only carry out the law, they cannot create it. Here they’re purporting to create an entirely new category called ‘marijuana extracts,’ and by doing so wrest control over all cannabinoids. They want to call all cannabinoids illegal. But they don’t have the authority to do that.”
Experts say listing cannabis among the world’s deadliest drugs ignores decades of scientific and medical data. But attempts to delist it have met with decades of bureaucratic inertia and political distortion.
Speculation is growing about the possibility that the U.S. Drug Enforcement Administration (DEA) will review by summer its “Schedule I” designation of marijuana as equal to heroin among the world’s most dangerous drugs. Very few Americans know of or understand the DEA’s drug-ranking process, and a review of cannabis’s history as a Schedule I drug shows that the label is highly controversial and dubious.
Disgraced Attorney General John Mitchell of the Nixon administration placed marijuana in this category in 1972 as part of the ranking or “scheduling” of all drugs under the 1970 Controlled Substances Act. Schedule I drugs are deemed to have no medical use and a high potential for abuse. Cannabis has been there ever since. “As of today, marijuana has never been determined to be medicine,” says Russ Baer, staff coordinator in the Office of Congressional and Public Affairs at the DEA. “There’s no safe, effective medical use, and a high abuse potential, and it can’t be used in medical settings.” This determination has come to be insulated by a byzantine, Kafkaesque bureaucratic process now impervious to the opinion of the majority of U.S. doctors—and to a vast body of scientific knowledge—many experts say.
“Of course cannabis has medical uses,” says University of California, San Francisco integrative oncologist Donald Abrams, one of the few researchers who have been able to obtain extremely limited, government-approved supplies of research cannabis for human trials. “It’s pretty clear from anthropological and archaeological evidence that cannabis has been used as a medicine for thousands of years—and it was a medicine in the U.S. until 1942,” Abrams adds. “I’m an oncologist and I say all the time, not a day goes by when I’m not recommending cannabis to patients for nausea, loss of appetite, pains, insomnia and depression—it works.”
Marijuana’s placement in Schedule I did not happen in a vacuum, historians note. Overt racism, combined with New Deal reforms and bureaucratic self-interest are often blamed for the first round of federal cannabis prohibition under the Marihuana Tax Act of 1937, which restricted possession to those who paid a steep tax for a limited set of medical and industrial applications. (Cannabis was removed from the official U.S. Pharmacopeia in 1942.) “In segregated America newspapers were saying, ‘this stuff makes white women and black men have sex,’” notes historian Martin Lee, author of Smoke Signals: A Social History of Marijuana.
The American Medical Association initially opposed prohibition. Cannabis was medically useful, says William Woodward, association counsel. “Congress being what it was at the time, you could ram things through just by bullshitting,” Lee adds. “Who’s going to be stepping up to the plate [in 1937] to defend a drug that blacks, Latinos and jazz musicians use?”
The Tax Act passed amid New Deal reforms, and the first marijuana peddlers were arrested and jailed that year. Science reared its head within a decade, though. In 1944 the La Guardia Committee report from the New York Academy of Medicine was the first in a long line of official bodies to question the prohibition. The committee found marijuana not physically addictive, not a gateway drug and that it did not lead to crime. But Harry Anslinger, head of the then–Federal Bureau of Narcotics, labeled the report unscientific and prohibition rolled on. “Every 10 years since then—although we’re a bit off schedule—some august governing body has reviewed the data and come up with the same finding [against prohibition],” Abrams says.
The Tax Act’s mode of federal cannabis prohibition became illegal in 1969 with the case Leary v. United States, which found that purchasing a marijuana tax stamp amounted to self-incrimination. The verdict spurred Congress to repeal the Tax Act and replace it with the more comprehensive Controlled Substances Act of 1970.
Marijuana was placed in Schedule I in 1971 provisionally, until the science could be assessed. But Pres. Richard Nixon saw pot prohibition as a way to destroy the antiwar left, according to clandestine recordings made by Nixon in the White House as well as statements from his staff to the press. Nixon convened The National Commission on Marihuana and Drug Abuse (what became known as the Shafer Commission) to engineer scientific support for cannabis’s Schedule I placement. “I want a goddamn strong statement on marijuana,” Nixon said in tapes from 1971. “Can I get that out of this sonofabitching, uh, domestic council? … I mean one on marijuana that just tears the ass out of them.”
The Shafer Commission found in 1972 that cannabis was as safe as alcohol, and recommended ending prohibition in favor of a public health approach. But by then the Federal Bureau of Narcotics had been removed from the Treasury Department and merged into the U.S. Department of Justice—where Nixon’s ally, Attorney General John Mitchell, placed cannabis in Schedule I in 1972; that same year he resigned to head Nixon’s re-election committee. (He later stood trial in 1974 over the Watergate scandal and served 19 months of a prison sentence for conspiracy, perjury and obstruction of justice.] “You want to know what this was really all about?” Nixon aid John Ehrlichman told journalist Dan Baum in 1994, according to an article published in Harper’s Magazine in 2016. “The Nixon campaign in 1968, and the Nixon White House after that, had two enemies: the antiwar left and black people. You understand what I’m saying? We knew we couldn’t make it illegal to be either against the war or black, but by getting the public to associate the hippies with marijuana and blacks with heroin, and then criminalizing both heavily, we could disrupt those communities. We could arrest their leaders, raid their homes, break up their meetings and vilify them night after night on the evening news. Did we know we were lying about the drugs? Of course we did.”
Anyone can petition the DEA to reschedule any drug, Baer says. The DEA takes advice from the U.S. Food and Drug Administration, Department of Health and Human Services, the DEA’s administrative law judges, along with others, but “the buck stops here. We have final scheduling authority,” he says. “Really it comes down to science. That’s the foundation of the argument. We’re bound by that scientific and medical evaluation.”
Many would disagree. Decades ago the DEA’s own administrative law judge, Francis Young, recommended unscheduling cannabis in response to a petition from activist groups. Young ruled in 1988 that “marijuana, in its natural form, is one of the safest therapeutically active substances known to man. By any measure of rational analysis marijuana can be safely used within a supervised routine of medical care.” The DEA denied the petition anyway.
In 1999, in response to California medical legalization, the Institute of Medicine found that marijuana had medical uses and a relatively low potential for abuse, leading to another round of petitioning. The DEA denied a petition again in 2011, citing a lack of available research specifically on smoked marijuana in the U.S.
Researchers say this represents a classic catch-22, as the paucity of research is the direct result of a federal blockade on such research by the DEA and the National Institute on Drug Abuse (NIDA). “The reason we don’t have more data is because it’s quite difficult to study. The only legal source of cannabis is NIDA, which has a Congressional mandate to only study its harms,” Abrams says. Researchers also note that about two dozen countries including Israel, Canada and the Netherlands as well as several legalization states such as California and Colorado, have reams of scientific data on the safety and efficacy of smoked cannabis as well as other formulations. While NIDA’s primary work focuses largely on studies involving drug abuse and addiction, the organization does fund some research on therapeutic uses for THC as well.*
Many physicians are also frustrated by the DEA’s apparent intransigence in the face of mounting evidence and interest. In 2009 the American Medical Association recommended the DEA review marijuana’s Schedule I status. And a 2014 Medscape survey of roughly 1,500 doctors found 56 percent supported legalizing medical cannabis nationally, with 82 percent support among responding oncologists. “If physicians are in support of cannabis as a medicine, why is it not medicine?” Abrams asks.
In 2014 lawmakers blasted DEA Administrator Michele Leonhart on the floor of Congress for failing to reply to questions about whether or not heroin was more or less dangerous than marijuana, which is also often used to treat pain. Both are Schedule I—yet cannabis has no obtainable lethal overdose threshold whereas 19,000 Americans died from prescription opioid overdoses in 2014 alone. Earlier this year a researcher at The Brookings Institution called for emergency rescheduling of cannabis to save American lives. All 2016 presidential candidates have vowed to either honor state-level medical legalization, reschedule cannabis or unschedule it entirely. “I think the federal government has forfeited any claim to credibility around cannabis,” Smoke Signals author Lee says. For example, although cannabis is Schedule I, the synthetic and pure form of the plant’s most hallucinatory ingredient, tetrahydrocannabinol, or THC, is in Schedule III alongside codeine under a pharmaceutical formulation called Marinol that can be legally prescribed for nausea and wasting. “I’ve taken [Marinol]. It’s horrible,” Lee says. “I can’t imagine how anyone in their right mind would think being on Marinol is safer than smoking weed. Marinol is like an edible—you can’t do anything.” Baer contends that pure THC is a single molecule, and therefore considered safer than the plant cannabis, which contains more than 300 types of molecules.
The FDA and Health and Human Services have given the DEA new rescheduling recommendations, but Baer would not say what they are. A potential change in scheduling could happen by summer, according to an interagency memo sent to eight lawmakers earlier this month. Marijuana’s Schedule I status “really is a national embarrassment,” Lee says. “It gives new meaning to the phrase, ‘the big lie’. It’s like saying, ‘The moon is made of green cheese.’ That this could remain until the present day is laughable only in that it keeps you from crying.”
Despite a degree of continued controversy, medical cannabis appears to be here to stay as a part of the armamentaria of physicians treating chronic pain. With the recent election, Massachusetts became the 18th state (in addition to the District of Columbia) to legalize cannabis for medical purposes. Although not everyone in the pain community has accepted cannabis as a viable form of treatment for chronic pain, the number of states allowing physicians to “prescribe” cannabis is increasing, with progressively more physicians considering treatment with cannabinoids a viable and safer alternative to much-maligned chronic opioid therapy, [1] despite concerns among some providers that the efficacy and safety of medical cannabis have not yet been adequately evaluated. [2] Although many physicians recognize the benefits of medical cannabis for purposes of pain management and a number of studies [3-6] have supported this efficacy, physician supporters of medical cannabis still often question the risk-benefit ratio as well as the strength of the evidence base of this approach to pain management. [7]
Medical use of cannabis has been legally controversial since California became the first state to allow its use for medical purposes with the passage of Proposition 215 in 1996. Its use still represents a violation of the Controlled Substances Act, which classifies it as Schedule 1 substance (ie, having high potential for dependence with no “accepted” medical use). [8] Cannabis has remained a Schedule 1 drug despite calls by the American Medical Association, the Institute of Medicine, and the American College of Physicians to reschedule it. [9] Notwithstanding being federally illegal, there were only limited challenges to the use of medicinal cannabis immediately following the passage of Proposition 215. However, with the George W. Bush administration, the federal government’s stance and behavior regarding medical cannabis changed drastically. While the Clinton administration, for the most part, assumed the position that the Controlled Substances Act did not apply to Schedule 1 drugs such as marijuana in states with medical marijuana laws in place, the Bush administration chose to eliminate its predecessor’s exception for medical use. [10]
Despite 2000 campaign claims that medical marijuana laws ought to be determined by individual states, the Bush administration aggressively suppressed states’ rights regarding this issue. Within Bush’s first year as president, the federal Drug Enforcement Administration (DEA) seized medical records of cannabis-using patients in California, destroyed the marijuana gardens of cancer and AIDS patients, and closed dispensaries providing medicinal cannabis to thousands of patients. [11] In September 2002, 30 DEA agents armed with M-16s burst into a medical marijuana hospice in Santa Cruz, California, and arrested its owners and a wheelchair-bound polio patient, thereby increasing the contention between the Bush administration and state leaders. [12] A month prior to the Santa Cruz raid, the DEA raided the home of Diane Monson, a California woman suffering from chronic low back pain due to a degenerative disease, and confiscated and destroyed 6 marijuana plants. Ms. Monson and Angel Raich, a California woman suffering from a malignant brain tumor who also used medical marijuana, then brought suit to prevent future raids. Although they lost their case, the Ninth Circuit Court of Appeals ruled in their favor. In (US Attorney General) Gonzalez v Raich, however, the US Supreme Court reversed the Appeals decision, stating that Congress has the right to “criminalize the private possession and medicinal use of cannabis, even on a licensed physician’s recommendation and under the protection of state law.” [13]
While campaigning for the Presidency in 2008, Barack Obama indicated that he did not support the use of federal resources as a means of circumventing individual states’ medical cannabis laws. [14] Within 2 months of President Obama’s inauguration, his newly appointed Attorney General, Eric Holder, announced that the administration would only pursue those who attempted to use state medical marijuana laws as a shield in order to pursue activities inconsistent with the intention of the state laws. [14] In October 2009, Holder appeared even more strongly in favor of medical cannabis rights when he acknowledged that although state programs violated federal law, pursuit of caregivers and patients compliant with the state laws would be given low priority. [15] However, the Department of Justice’s “nonenforcement policy” has not necessarily been consistently applied. While the number of dispensary raids has decreased markedly since the era of the Bush Department of Justice, raids still do occur. A rash of dispensary raids by the DEA in 2011 and 2012 has left state governments as well as suppliers and users of medical marijuana confused and angry. [16,17] In fact, over the past year, federal authorities shut down over 600 dispensaries in California alone. [18] Despite the increasing number of states permitting the sale and use of marijuana for patients under a physician’s care, the status of medical cannabis in the United States was, at best, somewhat perplexing even prior to the November 6, 2012 elections.
References
Lucas P. Cannabis as an adjunct to or substitute for opiates in the treatment of chronic pain. J Psychoactive Drugs. 2012;44:125-133. Abstract
Clark PA, Capuzzi K, Fick C. Medical marijuana: medical necessity versus political agenda. Med Sci Monit. 2011;17:RA249-261. Abstract
Rog DJ, Nurmikko TJ, Friede T, Young CA. Randomized, controlled trial of cannabis-based medicine in central pain in multiple sclerosis. Neurology. 2005;65:812-819. Abstract
Abrams DI, Jay CA, Shade SB, et al. Cannabis in painful HIV-associated sensory neuropathy: a randomized placebo-controlled trial. Neurology. 2007;68:515-521. Abstract
Wilsey B, Marcotte T, Tsodikov A, et al. A randomized, placebo-controlled, crossover trial of cannabis cigarettes in neuropathic pain. J Pain. 2008;9:506-521. Abstract
Reiman A. Cannabis as a substitute for alcohol and other drugs. Harm Reduction J. 2009;6:35.
Martín Fontelles MI, Goicoechea García C. Role of cannabinoids in the management of neuropathic pain. CNS Drugs. 2008;22:645-653. Abstract
Controlled Substances Act. 21 USC §802 (1970).
Hoffman DE, Weber E. Medical marijuana and the law. N Engl J Med. 2010;362:1453-1457. Abstract
Rosenbaum S. Gonzales v. Raich: implications for public health policy. Public Health Rep. 2005;120:680-682. Abstract
Kopel DB, Krause M. The drug war against civil liberty and human rights. A paper presented at the International Conference organized by the Liberal Institute, Friederich Naumann Foundation, Potsdam, Germany, September 18, 2004. http://www.davekopel.org/CJ/The-Drug-War-on-Human-Rights.pdf Accessed November 9, 2012.
Kreit A. The future of medical marijuana: should states grow their own? U PA Law Rev. 2002;151:1787-1826.
Carcieri MD. Gonzalez v. Raich: Congressional tyranny and irrelevance in the war on drugs. U PA J Const Law. 2007;9:1131-1165.
Sekhon V. Highly uncertain times: an analysis of the executive branch’s decision to not investigate or prosecute individuals in compliance with state medical marijuana laws. Hastings Const Law Q. 2010;37:553-563.
Gibson DT. Spreading the wealth: is asset forfeiture the key to enticing local agencies to enforce federal drug laws? Hastings Const Law Q. 2012;39:569-591.
Yardley W. New federal crackdown confounds states that allow medical marijuana. New York Times. May 8, 2011;a13.
Furlow B. States and US government spar over medical marijuana. Lancet Oncol. 2012;13:450.
Bazelon E. High noon on marijuana laws. Philadelphia Inquirer/Philly.com. November 9, 2012.
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