States, Federal Government Debate Use of Medical Marijuana

Phoenix—As a clinical pharmacy specialist at the Stratton Veterans Affairs Medical Center in Albany, New York, Jeffrey Fudin, PharmD, is prohibited from prescribing or dispensing marijuana. He is a federal government employee and must abide by US law that makes marijuana illegal.

The FDA has not approved marijuana for any indication; however, 23 states and Washington, DC, have enacted legislation that permits the use of medical marijuana and cannabis for certain conditions, including 8 states since 2010: Arizona, Connecticut, Delaware, Illinois, Massachusetts, Minnesota, New Hampshire, and New York. The rules vary statewide in terms of the conditions covered and access to the drugs.

Throughout the United States, legalizing marijuana and cannabinoids for medical use has become a hot button political issue. Cannabinoids are chemical compounds related to tetrahydrocannabinol (THC), the main psychoactive ingredient in marijuana. Proponents and detractors are debating the merits of the medications and whether the benefits outweigh the risks.

“I am in favor of having cannabinoids available by prescription,” Dr. Fudin said during a satellite symposium at the AAPM meeting. “But, I am not in favor of loosely allowing cannabinoids to be dispensed haphazardly without controls.”

Safety and Efficacy Research Still Needed
After California became the first state to legalize medical marijuana in November 1996, the White House Office of National Drug Control Policy asked the Institute of Medicine (IOM) to The IOM, a nonprofit organization affiliated with the National Academy of Sciences, released the report in 1999 and found that cannabinoids have “potential therapeutic value” for pain relief, control of nausea and vomiting, and appetite stimulation. The authors recommended scientists initiate clinical trials to examine the use of cannabinoids to manage and relieve symptoms.

Still, research on the effectiveness and safety of marijuana is limited because it has been classified under the Controlled Substances Act as a schedule 1 drug since 1970. The Drug Enforcement Agency (DEA) defines schedule 1 drugs as having “no currently accepted medical use in the United States, a lack of accepted safety for use under medical supervision, and a high potential for abuse.”

On the FDA’s Web site, the agency acknowledges that healthcare professionals and patients are interested in evaluating marijuana to treat glaucoma, AIDS wasting syndrome, neuropathic pain, cancer, multiple sclerosis, and seizure disorders. Before pharmaceutical manufacturers can start clinical trials for medical marijuana, they must obtain the drug from the National Institute on Drug Abuse, submit a new drug application to the FDA, and register and receive permission from the DEA to conduct research.

“I think the most important issues are the science behind the cannabinoids,” Dr. Fudin said. “I think that marijuana could be a good thing, but I think we need a much better understanding. I think there may be some excellent outcomes, but we need to study it.”

Although Dr. Fudin is in favor of medical marijuana in some cases, he stressed that healthcare professionals should be careful when considering when to prescribe the drugs. Dr. Fudin, who has taught pain management at several colleges and runs a pain management blog (www.paindr.com), is particularly concerned with patients who use marijuana in combination with other pain medications, especially opioids. He mentioned the combination of opioids, benzodiazepines, and alcohol is a potentially lethal mixture.

Risky Results
Stephen Ziegler, PhD, pain management specialist, associate professor, Indiana University-Purdue University Fort Wayne, said smoking marijuana raises similar concerns with cigarettes, such as cancer and other respiratory conditions. According to the Centers for Disease Control and Prevention (CDC), cigarette smoking causes an estimated 480,000 deaths per year, including deaths from secondhand smoke. The CDC also estimates that life expectancy for cigarette smokers is at least 10 years shorter than for nonsmokers.

In the IOM report, the authors noted, “Smoked marijuana is a crude THC delivery system that also delivers harmful substances.” According to the National Institute on Drug Abuse, marijuana smoke contains as much tar and 50% to 70% more carcinogens than tobacco smoke. “Few legitimate healthcare providers would recommend smoking as the delivery method,” Dr. Ziegler said.

Instead, Dr. Ziegler and Dr. Fudin suggested medical marijuana is safer when administered orally or via a nasal inhaler. The FDA has approved 2 oral cannabinoids (nabilone and dronabinol) to treat nausea and vomiting in patients who have cancer and are receiving chemotherapy.

In April, the FDA granted a fast track designation for a cannabinoid oromucosal mouth spray to treat pain in patients with advanced cancer. The product is intended for patients who had an inadequate response to chronic opioid therapy.

Dr. Ziegler and Dr. Fudin said they both would like the DEA and FDA to classify marijuana as a schedule 2 drug in order to make it easier to test in clinical trials. They also favor the states’ ability to regulate marijuana.

“States ultimately are allowed to experiment [with marijuana rules], and they should be permitted to [do so],” Dr. Ziegler said.

State-by-State Legislation
Colorado and Washington have recently legalized marijuana for recreational use, production, and distribution, but it remains unlikely that the federal government will change its stance on legalizing marijuana, according to Dr. Ziegler. He noted that the DEA “has a long history of opposition to marijuana whether it be medicinal or recreational.” The DEA has mentioned marijuana can lead to memory loss, distorted perception, trouble with thinking and problem-solving, loss of motor skills, decrease in muscle strength, increased heart rate, and anxiety.

In 2012, an estimated 18.9 million people in the United States ≥12 years of age used marijuana illegally in the previous month, according to the DEA. The Drug Abuse Warning Network found that there were 455,688 emergency department visits related to marijuana use in 2011, the second highest total for illicit drugs behind cocaine.

Still, states have jurisdiction over their own narcotics laws, and the FDA has spoken with states such as Florida, Georgia, New York, and Pennsylvania that have expressed interest in researching marijuana for medical purposes to make sure they follow guidelines and standards (Table).

In addition, as of May, 237 researchers had registered with the DEA to conduct studies with marijuana, marijuana extracts, and non-THC marijuana derivatives. According to the DEA, the trials include evaluation of abuse potential, physical/psychological effects, adverse effects, therapeutic potential, and detection. The agency also said 16 researchers are conducting trials on smoked marijuana among humans.

“As a policymaker, the 1 thing I can say is maybe this issue is not as cut and dry as [we] thought,” said Robert Twillman, PhD, deputy executive director, director of policy and advocacy, AAPM. “We seem to have some conflicts between state laws and federal laws. Maybe it is not [certain] that [marijuana] helps with most kinds of pain, but maybe it does. It might be hard to regulate as a prescription drug.”—Tim Casey