Marijuana Studies Program 7 January 2015
This brief report summarizes key issues that surround 1) the science that supports marijuana-based medicines compared to 2) marijuana that is legalized for medical use by voters via ballot initiatives or by elected officials.
1. FDA Protection—This section describes how the Food and Drug Administration protects Americans from unsafe, ineffective drugs. All medicine-makers must prove their medicines are first safe and then effective to obtain FDA approval to market them to the public. Approval is gained by proving a drug is safe in animal testing, then proving it is effective in humans through randomized clinical trials.
2. Medical Marijuana—No producer has applied to FDA for approval of any medical marijuana (MMJ) product. Doctors cannot prescribe them and pharmacies cannot sell them. Doctors can only recommend them or certify that a patient has a disease/condition that laws claim MMJ will cure/relieve.
3. Marijuana-Based Medicines—Marinol® and Cesamet® are synthetic (man-made) THC, approved by FDA in the 1980s to treat chemotherapy-related nausea and AIDs wasting in patients who do not respond to standard medications. There is no need to legalize marijuana-based medicines. They are legal for patients to possess and use while taking part in research studies and clinical trials and with a prescription once the drugs are approved by FDA.
4. Marijuana Based Medicines Seeking FDA Approval—Sativex®, combined THC and CBD, and Epidiolex®, CBD, are in clinical trials in the US to treat advanced cancer pain and intractable epileptic seizures, respectively. The British firm GW Pharmaceuticals grows marijuana without the use of pesticides and purifies the THC and CBD extracted from the marijuana. Insys Therapeutics plans to begin clinical trials in 2015 of its marijuana-based medicine, synthetic CBD, to treat epileptic seizures.