David C. Edholm, MJLST Staffer
“The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human . . . drugs.” To no surprise, near the top of the FDA’s list of current priorities is ameliorating the prescription opioid epidemic. More than 14,000 deaths in 2019 are attributed to prescription opioid overdoses. (See fig. 4 of hyperlink). Celebrity opioid overdoses have raised public awareness of the crisis, however, hundreds of millions of opioid prescriptions are written each year to treat “moderate-to-severe” pain. The epidemic continues today, begging the question of whether any reasonable alternatives to prescription opioids exist, perhaps medical cannabis.
California became the first state to legalize medical cannabis through a ballot initiative in 1996; since then, 35 states and four territories followed. Although the Department of Health and Human Services and the FDA have expressed skepticism about safety and efficacy due to a lack of quality research, legalization in a recreational capacity is becoming more popularized. Recent systematic studies on high-potency cannabis products have shown a cause for concern, however, studies on substituting medical cannabis for prescription opioids remain inconclusive, leaving the door open to this future possibility.
In order for medical cannabis to legitimately contend with prescription opioids, quality safety and efficacy data are required. But the public stands by as FDA has yet to approve a medical use and “marihuana” remains a Schedule I controlled substance. 18 U.S.C. § 812(1) (2018). Recent federal efforts push for decriminalization, but historically the federal government has adopted a “hands off” approach, giving states choice on cannabis regulation. There is coast-to-coast differentiation on cannabis legalization with most states permitting medical use and a growing number permitting recreational use, but due to its current state of being under-researched, it is substantially less controversial to leave the political choice for legalization to the states as long as safety and efficacy are opaque.
The benefit of state choice is articulated through efforts from states like California and Minnesota that aid the national effort to clarify safety and efficacy in legitimate ways. California, for example, allows medical and recreational use, as a result providing a vast data cohort. The state senate bill reads, “[i]t is the intent of the legislature that the state commission objective scientific research by . . . the University of California, regarding the safety and efficacy of administering cannabis as part of medical treatment.” Additionally, Minnesota, which permits medical use and submitted a bill for recreational approval now pending in the senate, created a medical cannabis patient registry that accumulates data, generates reports, and submits the reports to legislature and prominent medical journals that are available to the public. These states are among others providing similar efforts.
Medical cannabis may be an alternative for prescription opioids, yet there remain several questions about safety and efficacy that must be answered in order for the FDA to move on any milestone cannabis regulation. It seems that severe risks posed by cannabis are extremely rare, and are not a public health threat requiring immediate attention. Prescription opioids remain standard treatment post-operation or post-physical trauma and are usually prescribed for short-term use, but 20% of post-op patients still use opioids three months after surgery, despite an increased risk of addiction after only a few days of use. It seems the opioid epidemic is here to stay as long as prescribing practices remain the same, at least until an effective alternative arises. Maybe cannabis will be a solution. It depends on the data.