Always a hot topic, the legality of medical marijuana was, yet again, thrown into the spotlight in March when the DEA approved a synthetic marijuana drug and classified synthetic marijuana as a Schedule II controlled substance.
Now legal in 29 states and the District of Columbia, naturally-grown marijuana has been listed as a Schedule I controlled substance under the Controlled Substances Act since 1970, marking it as dangerous as heroin. Federal agencies haven’t always seen eye-to-eye over drug classifications, however.
In September 2016, public records obtained by ATTN revealed the FDA’s concerns over the DEA’s scheduling system, citing the difficulty of establishing the role and value of medical marijuana under the current legal and regulatory framework. Flames are now being fanned even higher, thanks to the DEA’s recent ruling on lab-produced marijuana.
In March 2017, a major pharmaceutical company – which is known to strongly oppose the legalization of medical marijuana – was granted a preliminary approval from the DEA for its new synthetic marijuana drug. Phoenix-based Insys Therapeutics is the pharmaceutical company in question, and the drug is Syndros – an oral solution that contains a synthetic formulation of THC, the main psychoactive ingredient in marijuana and the compound that gets users ‘high’.
That caught the attention of marijuana reform advocates who pointed out that, ironically, the DEA’s statement that Syndros has the same potential for abuse as “other THC-containing products such as concentrates, infused edibles, and drinks.” This led to wide criticism of regulating bodies and accusations of inconsistencies among rulings.
Insys Therapeutics also happens to be the very same pharmaceutical company that donated a staggering half a million dollars to the Arizonans for Responsible Drug Policy, a group that opposed marijuana legalization in Arizona. Insys, whose CEO is billionaire John Kapoor, was the only pharmaceutical company known to oppose marijuana legalization last year; their attempt to thwart Arizona’s popular Proposition 205 proving ultimately proved successful when voters rejected the bill.
Insys has also actively advocated for restrictions on medical marijuana, particularly medicines containing the psychoactive compound THC.
Classification of Marijuana in the US
The FDA’s classification of naturally-grown marijuana as a Schedule I controlled substance not only puts it in the same brackets as drugs such as heroin, ecstasy and LSD, but states that it has no known medicinal value and is very likely to be abused – factors that are determined by the FDA. Additionally, researchers working with Schedule I drugs need to be licensed and their procedures must meet federal requirements and scientific standards, which can slow important research in the field.
But now, following the DEA’s approval of Syndros, the synthetic marijuana drug and its generic formulations fall into the less restrictive Schedule II classification, joining cocaine, methamphetamine and most opioid painkillers.
Synthetic Marijuana for Cancer Patients
Synthetic marijuana is made from lab-synthesized cannabinoids such as tetrahydrocannabinol (THC) and cannabidiol (CBD). In their natural state, these compound extracts are derived from marijuana and widely used in the treatment of various conditions ranging from nausea, eating disorders, and Alzheimer’s, to anxiety, depression, and migraines.
Insys Therapeutics’ Syndros THC drug will be used to help cancer patients battle the after-effects of chemotherapy, such as nausea and vomiting. Many traditional marijuana users, however, are against the introduction of Syndros into the medical marijuana market due to concerns over the drug’s active THC ingredient, the man-made dronabinol.
In fact, the classification of Syndros as a Schedule II drug has come under sharp criticism from various groups, particularly since the DEA had earlier communicated that all extracts from marijuana were to be classified as Schedule I. Rather confusingly, in December 2016 the DEA even classified three different synthetic cannabinoids as Schedule I substances.
The recent ruling of Syndros did come after a recommendation by the FDA, however, who themselves approved the drug on July 1, 2016, stating that it effectively treated nausea and vomiting among chemotherapy patients, as well weight loss associated with AIDS.
Syndros aside, a number of lawmakers and health officials have called for the ban of other forms of synthetic marijuana including K2 and Spice, which have been sold at smoke shops around the country. In New York alone, more than 30 people overdosed after using synthetic marijuana drugs in July 2016. Naturally-grown marijuana, meanwhile, has no reported overdose deaths, yet remains classified as a Schedule I drug.
Effect of DEA’s Schedule II Classification of Synthetic Marijuana on the Medical Marijuana Community
The DEA’s decision to approve a major pharmaceutical company’s synthetic medical marijuana drug has caused a quite a stir among the traditional medical marijuana community and will no doubt lead to intense disputes with the predicted influx of pharmaceutical companies looking to cash in on the Schedule II classification.
The potential that Syndros will be widely used as an alternative to natural marijuana has many vendors fearing for their businesses. They are rightly concerned that Insys Therapeutics’ foray into the lucrative marijuana market will pave the way for other large pharmaceutical companies to follow, potentially making life very difficult for smaller and independent natural medical marijuana dispensaries.
Through his newsletter, Marijuana Moment, Marijuana Majority founder Tom Angell states that Insys Therapeutics are purely in it for the money and do not care about the health of patients. Comparing Syndros to fentanyl, a highly dangerous opioid the company also produces, Angell argues that by only making a concentrated version of marijuana legal – incidentally, a form that will fetch good prices in pharmacies across the US – the integrity of the ruling bodies has been undermined.
It’s also worth keeping in mind that, in addition to opposing the legalization movement in Arizona, Insys is the subject of numerous state and federal criminal investigations, and a shareholder class action lawsuit is currently underway over the company’s aggressive marketing of a product containing the previously mentioned controversial opioid painkiller fentanyl.
Now that it is FDA approved, synthetic marijuana has the potential to impose on traditional medical marijuana vendors’ customer bases. Patients that may have otherwise sought the benefits of natural marijuana could have their heads turned by heavyweight pharmaceutical companies riding on big investments and federally approval studies backing up their claims. Not to mention, practitioners may feel less anxious about writing a legal Schedule II prescription over a federally illegal Schedule I.
Traditional medical marijuana vendors may also lose out on referrals by medical practitioners, who could infer synthetic medical marijuana as being safer than natural marijuana due to numerous drug trials providing hard stats on the drug’s efficacy.
Furthermore, the costs incurred researching and manufacturing synthetic medical marijuana drugs such as Syndros are expected to be passed on to the consumer, likely to result in the drug costing more than naturally-grown medical marijuana. And, as most patients with a medical marijuana prescription already spend heavily on other medications, an increased billing for synthetic medical marijuana would further stretch their finances.
In a worse case scenario, traditional medical marijuana, which can be easily grown at home, may one day be forced out of the market by cheap-to-produce synthetic variations. Government institutions may seek to increase the blanket regulation of traditional marijuana use, pointing to studies supposedly proving its susceptibility to abuse.
Should this happen, big pharmaceutical companies would have complete control over the marijuana market. And with mental health problems across the country soaring, patients may well come to rely on these synthetic products and their unsavory manufacturers.
That’s still a long way off, though, and hopefully, the inconsistencies highlighted by this recent ruling on synthetic marijuana will lead to more honest conversations on the merits of whole-plant marijuana. With a bit of luck, common sense will prevail and federal authorities will backtrack on their outdated beliefs and marijuana will be awarded the recognition and appreciation it deserves.