Partnership to End Addiction encourages research on the medicinal value of marijuana and the use of any U.S. Food and Drug Administration (FDA)-approved medications derived from marijuana or containing cannabinoids. However, the Partnership opposes state “medical marijuana” laws because they bypass the FDA review process.
The FDA’s process for approving new drugs is the current standard for verifying that a medication is safe and effective for a particular indication. The FDA evaluates data on the safety, efficacy, dosage and side effects of new medicines and oversees the manufacturing process to ensure quality control and proper labeling. Without FDA review, there is no centralized evaluation of the evidence to determine whether a drug works to treat a specific condition and what dose is safe and effective.
State “medical marijuana” laws by-pass FDA review and allow patients to use marijuana if they have specific medical conditions approved by the state. Some states currently list medical conditions (e.g., some psychiatric and neurological disorders) based primarily on anecdotal reports, expert opinions and non-randomized studies. There is not sufficient high-quality evidence from randomized, controlled clinical trials to determine whether marijuana is actually safe and effective for treating most of these conditions. State medical marijuana laws also create a distribution channel that lacks sufficient oversight of standardization and purity of each “dose.” Furthermore, state marijuana laws approve smoked marijuana as medicine. Smoking is not a medically-accepted route of administration for any medication because smoking can damage the lungs and results in second hand exposure.
High-quality research has found that individual components of marijuana, known as cannabinoids, have therapeutic value for select health conditions, including chemotherapy-induced nausea and unwanted weight loss from AIDS. The two cannabinoids that are most studied for their therapeutic value are delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). THC is responsible for the intoxicating (“high”) effects of marijuana; CBD does not cause intoxication.
The FDA has approved two THC-based drugs, Cesamet (which contains a compound similar to THC) and Marinol (which contain THC). The FDA is currently reviewing clinical trials of drugs that contain CBD only and drugs with a combination of CBD and THC. More research is needed to develop better medications. Cesamet and Marinol are not ideal and may offer inadequate treatment because of their poor time of onset, duration of action, and time of offset. Some have suggested that cannabinoids are less effective when isolated and that whole-plant based drugs are more effective.
Partnership to End Addiction strongly encourages more high-quality research on the medicinal value of cannabinoids to treat health conditions. While administrative and legal barriers (including marijuana’s DEA classification as a Schedule I drug) make it difficult to conduct such research, forgoing FDA review and allowing state legislators or voters to make health care decisions without this centralized review of the evidence poses an unacceptable risk to the public’s health.
The FDA is currently reviewing the medical evidence supporting the safety and effectiveness of marijuana for medical purposes. The FDA’s review may result in a recommendation that the drug be downgraded from Schedule I, which would create more opportunities for research and treatment.
To protect public health and encourage research on the potentially therapeutic components of marijuana, Partnership to End Addiction recommends the following:
- The National Institutes of Health (NIH) should develop streamlined procedures to increase research on the utility of cannabinoids for medical use and encourage the development of better THC-based, FDA-approved medications.
- NIH and the Institute of Medicine of the National Academy of Sciences should convene regular meetings to evaluate research data on therapeutic indications for cannabinoids and, when appropriate, make recommendations to the FDA about approving new indications.
- State policymakers, physicians and patient advocates should work to encourage or fund research to test the safety and efficacy of marijuana-based and cannabinoid medications.
- States that have approved “medical marijuana” should:
- Establish surveillance programs to monitor safety, adverse events and outcomes, and
- Provide education to prescribers and consumers about the risks associated with marijuana including risks associated with altered sensorium (accidents, inability to work or study effectively, etc.), cognitive deficits, addiction and psychosis.