At the close of 2018, the U.S. Surgeon General Jerome Adams called on the federal government to rethink marijuana’s classification as it pertains to medical research. While the Surgeon General did not go so far as to condone legalization for recreational use, he did say that medically, marijuana should be studied, noting, “While I support local solutions to help solve our national public health challenges, they must be led by science driven policy. Currently, NIH funded research on marijuana is pressing forward and we are making progress in studying marijuana and its impact on the human brain, body, and behavior as well as on our communities. We should continue to seek ways to encourage and enable research to best inform policies regarding the potential medicinal properties of marijuana.”
Because the cannabis plant is made up of hundreds of different chemical entities, there is much to learn about the array of chemical compounds– individually and in combination– that could provide medical treatment across many health states. The FDA has already approved cannabinoid oil and other derivatives of the plant for treatment of everything from anxiety to epilepsy. Further, as the nation faces an opioid epidemic, discussions surrounding non-opioid pain relief options are growing around Capitol Hill, with cannabinoids at the top of the list.
While the Surgeon General is right in his position on medical research, the move would serve other purposes as well. The change he proposed could be significant for justice system reforms and an economic triumph for the U.S. His belief– and that of researchers around the world– is that the current U.S. classification of marijuana inhibits research for medical advancements that include cannabis and cannabinoids, with the U.S. falling behind in both knowledge and financing. Not only are countries such as China and Israel lapping the U.S. in medical innovations and research, but G7 countries like Canada are earning billions of dollars by having legalized cannabis. For example, in the latter six months of 2018, Canada’s market has run wild with IPOs, including American-based cannabis companies flooding the market.
“The relevance of the Surgeon General’s call to reschedule cannabis cannot be understated,” says Dr. Mark Rosenfeld, CEO of ANANDA Scientific. “The chemistry found only in cannabis plants can provide relief across an incredible array of adverse health states. It does this with minimal side effects and with the prospect of being eminently cost-effective in its use.” He goes on to explain that, “The medicinal use of cannabis today has its roots in the 1960s, when Israeli scientists began studies on its unique chemistry. A government program for administering medical cannabis has been in place there for 12 years, and doctors do not hesitate to encourage its use as an effective pharmaceutical alternative. Meanwhile, the United States remains regrettably behind because of its draconian and antiquated anti-cannabis laws. In no small way due to the regulatory and legal nightmare defining the situation for medical cannabis in the U.S., the science supporting its medicinal efficacy remains tentative. But reversing the excessively harsh and prohibitive laws for cannabis in the United States remains essential for making cannabis chemistry real human medicine. It is important to realize that states have approved the medicinal use of cannabis through legislative processes, not scientific or medical ones. That has gotten in the way of scientists determining with certainty the therapeutic impact of cannabis and thus of patients wishing to beneficially use it.
Billions On The Table
The Surgeon General’s public comments come alongside a congressional report released this week entitled, “The National Cannabis Economy,” highlighting economic benefits of legalized cannabis at the state and national levels. The report concludes that this year alone more than $11 billion will be earned by the marijuana industry, and that sales will reach $23 billion by 2022 due to, “job creation, more tax revenue, and better patient care.”
Of additional interest to federal lawmakers should be revenue projections that estimate the medical segment of the market will surpass the recreational segment of the market within four years, due to the need for opioid alternatives for pain management as well as chronic diseases. Thus, those trying to improve the regulatory environment and sustainability of a cannabis market agree with the academic researchers and the Surgeon General. Jeffrey M. Zucker, President of Green Lion Partners says, “It’s great to see Surgeon General Adams coming out in support of cannabis reclassification. We still know relatively little about the possible uses of this plant. Our inability to conduct extensive research in the U.S. has led to countries like Canada and Israel jumping far ahead of us before we’ve even really got into it from both scientific and economic perspectives. The discoveries they are making are life-changing for many, and I can only imagine the depth of discovery possible with the U.S. government supporting more research. There are a lot of pharmaceuticals with rough side effects that can potentially be replaced by various forms of cannabis, but it is going to take a focus on science and compassion to get there.”
Garyn Angel, CEO of MagicalButter.com, an American company that has seen the global market leave the U.S. in the dust, adds that from an economic perspective, “As cannabis legalization moves forward globally, we are leaving a huge market opportunity on the table here in the U.S.— there are billions of dollars to be made in research, innovation, cultivation, product development and retail sales.” He claims, “By reclassifying cannabis, the U.S. could potentially capture millions in tax revenue, bolstering our economy and encouraging funding of scientific innovation in the process. Every day that we aren’t working to lead the charge in this new “green rush,” we risk being left behind as the global market grows more sophisticated.”
In June, Canada became the second nation in the world after Uruguay (first G7 nation) to fully legalize cannabis. The result has been global surges in stocks and private sector deals with pharmaceutical companies such as Novartis to research and distribute medical marijuana.
In addition to sales and tax revenue being left on the table, the U.S. is also trailing when it comes to R&D, as well as intellectual property (IP). Countries like China and Israel, where federal funds are appropriated for cannabis research, are seeing vigorous innovations that could shift the entire global market for pain relief within the world’s aging population alone. Not to mention medical breakthroughs for rare and chronic diseases across the life span. China, which has become the world’s powerhouse in research, holds more than half of the world’s 600 cannabis-related patents. And Israel currently has more than 110 clinical trials involving cannabis.
The DEA Is In The Way
The U.S. Drug Enforcement Administration (DEA) classifies drugs, substances, and certain chemicals used to make drugs into five distinct categories or “schedules” depending upon the drug’s acceptable medical use and the drug’s abuse or dependency potential. According to the website, “The abuse rate is a determinate factor in the scheduling of the drug; for example, Schedule I drugs have a high potential for abuse and the potential to create severe psychological and/or physical dependence. As the drug schedule changes– Schedule II, Schedule III, etc., so does the abuse potential– Schedule V drugs represents the least potential for abuse.”
Schedule I drugs, substances and chemicals–like marijuana– are defined as drugs with no currently accepted medical use. Further, they are considered to have a very high potential for abuse. In comparison to marijuana, other drugs in this category are heroin, lacid diethylamide (LSD), 3, 4-methylenedioxymethamphetamine (ecstasy), methaqualone and peyote. Which begs the question how the FDA can have already approved cannabis for medical use, and yet the chemical stays with the likes of LSD and heroin.
Moreover, Schedule II drugs (which are considered less dangerous and less addictive) include the likes of substances that many cannabinoid compounds could prevent individuals from becoming addicted to, such as hydrocodone (Vicodin), cocaine, methamphetamine, methadone, oxycodone (OxyContin), fentanyl, Adderall and Ritalin. Making it hard to believe that even a federal agency classifies marijuana as meaningfully more dangerous than meth.
However, in recent months, the DEA has released a Final Order rescheduling FDA-approved cannabis-derived Cannabidiol (CBD) with no more than 0.1% THC under Schedule V. The decision came after pressure from both the FDA and HHS, but has since gone in circles between the agencies.
But the biggest step forward might be taken with the passage of the 2018 Farm Bill. Buried in the 1,000-plus-page document (Section 7415) are removal of hemp from the Controlled Substance Act (CSA), and redefining how extracts, cannabinoids and derivates of CBD can be legal. Despite this progress, many regulatory questions remain unanswered, and the growing, selling, purchasing and research associated with various components of plants will come under much scrutiny in coming months.