THE RED SECTION
nature publishing group
161
Is the Hype of Medical Marijuana All Smoke and Mirrors? Jenna Koliani-Pace, MD1 and Corey A. Siegel, MD, MS1
Being classified as a Schedule I drug by the Federal government has not prevented states from passing their own medical marijuana laws. While there is no denying that marijuana’s euphoria makes people feel better, there is a lack of scientific data to support the efficacy of marijuana for gastrointestinal diseases. Marijuana, when used as a medical treatment, should be held to the same standards as any other drug coming to market including investigating the adverse event profile and ensuring a rigorous quality control program. Although we are not writing a prescription in the classic definition, we are signing state paperwork supporting the use as a treatment for a medical illness. Therefore, we have the obligation to our patients to ensure that we are recommending a safe and effective drug. More research needs to be conducted until we can reach that conclusion. Am J Gastroenterol 2016; 111:161–162; doi:10.1038/ajg.2016.4; published online 9 February 2016
Undoubtedly, archaeologic records indicate that humans have been using marijuana both medicinally and recreationally for centuries. Marijuana’s popularity is derived from the “high” or euphoria that is caused by delta-tetrahydrocannabinol (THC), one of hundreds of compounds that have been isolated from cannabis. Despite marijuana being labeled as a Schedule 1 drug alongside heroin and ecstasy, ~12% of people aged 12 years or older report using cannabis in the past year (1). In contrast to the federal government, many states see the therapeutic potential for cannabinoids and have thereby authorized its medicinal use as medical treatment to allow people to gain access without fear of prosecution; a few states have also approved its recreational use (2). We are not commenting on the social experiment being conducted in this country with recreational marijuana, or doubting that there may be therapeutic uses for this drug. Rather, we are stating that marijuana should be handled like any other drug physicians prescribe to their patients, which have gone through the rigorous Food and Drug Administration (FDA) approval process. Compared with the typical evidence required of drugs reaching the market, the data for marijuana are scant. The standard path of a phase 2 study would be focused on safety and dose ranging, followed by two phase 3 randomized controlled trials (RCTs) with some comparator (e.g., approved anti-emetic, pain medication, appetite stimulant, or placebo). Furthermore, the FDA has been pushing objective outcome measures in addition to patient-reported outcomes as study end points, which is particularly important for a psychoactive drug causing euphoria. For example, Naftali et al.
assessed the effect of cannabis therapy for patients with Crohn’s disease in a placebo-controlled RCT. Although they did demonstrate a significant response based on a decrease in the subjective Crohn’s Disease Activity Index, they did not evaluate marijuana’s effect on intestinal inflammation endoscopically, or with objective measures like C-reactive protein or fecal calprotectin (3). As one of our colleagues elucidated during the question and answer session when this paper was presented at a National meeting, “so you showed that patients who smoked marijuana had a better quality of life, a better appetite, and had a higher satisfaction with treatment as compared with placebo, without any objective markers of inflammation.” Our bar needs to be higher. There is a great lack of controlled evidence in other gastrointestinal diseases as well. In a recent systematic review across all gastrointestinal diseases, a total of five manuscripts were identified including
nature publishing group
161
Is the Hype of Medical Marijuana All Smoke and Mirrors? Jenna Koliani-Pace, MD1 and Corey A. Siegel, MD, MS1
Being classified as a Schedule I drug by the Federal government has not prevented states from passing their own medical marijuana laws. While there is no denying that marijuana’s euphoria makes people feel better, there is a lack of scientific data to support the efficacy of marijuana for gastrointestinal diseases. Marijuana, when used as a medical treatment, should be held to the same standards as any other drug coming to market including investigating the adverse event profile and ensuring a rigorous quality control program. Although we are not writing a prescription in the classic definition, we are signing state paperwork supporting the use as a treatment for a medical illness. Therefore, we have the obligation to our patients to ensure that we are recommending a safe and effective drug. More research needs to be conducted until we can reach that conclusion. Am J Gastroenterol 2016; 111:161–162; doi:10.1038/ajg.2016.4; published online 9 February 2016
Undoubtedly, archaeologic records indicate that humans have been using marijuana both medicinally and recreationally for centuries. Marijuana’s popularity is derived from the “high” or euphoria that is caused by delta-tetrahydrocannabinol (THC), one of hundreds of compounds that have been isolated from cannabis. Despite marijuana being labeled as a Schedule 1 drug alongside heroin and ecstasy, ~12% of people aged 12 years or older report using cannabis in the past year (1). In contrast to the federal government, many states see the therapeutic potential for cannabinoids and have thereby authorized its medicinal use as medical treatment to allow people to gain access without fear of prosecution; a few states have also approved its recreational use (2). We are not commenting on the social experiment being conducted in this country with recreational marijuana, or doubting that there may be therapeutic uses for this drug. Rather, we are stating that marijuana should be handled like any other drug physicians prescribe to their patients, which have gone through the rigorous Food and Drug Administration (FDA) approval process. Compared with the typical evidence required of drugs reaching the market, the data for marijuana are scant. The standard path of a phase 2 study would be focused on safety and dose ranging, followed by two phase 3 randomized controlled trials (RCTs) with some comparator (e.g., approved anti-emetic, pain medication, appetite stimulant, or placebo). Furthermore, the FDA has been pushing objective outcome measures in addition to patient-reported outcomes as study end points, which is particularly important for a psychoactive drug causing euphoria. For example, Naftali et al.
assessed the effect of cannabis therapy for patients with Crohn’s disease in a placebo-controlled RCT. Although they did demonstrate a significant response based on a decrease in the subjective Crohn’s Disease Activity Index, they did not evaluate marijuana’s effect on intestinal inflammation endoscopically, or with objective measures like C-reactive protein or fecal calprotectin (3). As one of our colleagues elucidated during the question and answer session when this paper was presented at a National meeting, “so you showed that patients who smoked marijuana had a better quality of life, a better appetite, and had a higher satisfaction with treatment as compared with placebo, without any objective markers of inflammation.” Our bar needs to be higher. There is a great lack of controlled evidence in other gastrointestinal diseases as well. In a recent systematic review across all gastrointestinal diseases, a total of five manuscripts were identified including
