Sep 9, 2016 9:20 AM

Struggle of PTSD Marijuana Research Continues

This year has been a critical time for two significant but still controversial medical issues: research on post-traumatic stress disorder and the use of recreational drugs like marijuana to treat it.

Struggle of PTSD Marijuana Research Continues

PTSD has become an epidemic in the United States. The U.S. Department of Veteran Affairs estimates that nearly eight million Americans, many of whom are military veterans returning from combat, currently have PTSD. And this is only a small portion of those who have gone through at least one traumatic event: 70 percent of American adults have experienced some type of trauma at least once in their lives, and 8 percent of all Americans (nearly 24.4 million people) have PTSD at any given time.

DEA Finally Approves PTSD Marijuana Study

In April 2016, the U.S. Drug Enforcement Administration approved the first-ever study on the effect of medical marijuana on the U.S. military veterans with post-traumatic stress disorder (PTSD).

It was announced that the study would be funded by a $2.2 million grant from the State of Colorado awarded to the Multidisciplinary Association for Psychedelic Studies (MAPS). The scientists are going to test the efficacy and safety of different strains of botanical marijuana in 76 military veterans diagnosed with PTSD resistant to conventional treatment.

There have not been controlled studies so far that evaluate the effectiveness of cannabis use for PTSD among veterans, but numerous neurologists point out that patients show increased receptiveness to the CB1 receptors compared to healthy individuals. Many veterans say smoking the plant has significantly eased their symptoms.

If the study shows cannabis to be a successful treatment, the researchers will seek for FDA approval for the plant to be prescribed to anyone with PTSD, said Brad Burge, a director of communications for MAPS.

The study has already been approved once, in 2014, but was put on hold after the University of Arizona fired the primary researcher, Dr. Sue Sisley. Then, Dr. Sisley said that the reason for dismissal had its roots in politics because she had clashed with state lawmakers over medical marijuana research.

The DEA's approval meant that the clinical trial, which had been stalled for almost six years, could finally move forward. However, it is not as easy as it might seem.

To Recommend or Not To Recommend? That Is the Question

Currently, 25 states and Washington D.C. have already legalized cannabis for medical use. Marijuana is used for treating more than three dozens of debilitating conditions, including Parkinson's disease, multiple sclerosis, HIV/AIDS, lupus, and Alzheimer's. In six states (Arizona, Connecticut, Maine, Delaware, Pennsylvania, and New Mexico), PTSD is an approved condition for medical marijuana. Three others—California, Massachusetts, and the District of Columbia—allow doctors to recommend medical cannabis for conditions that are not specifically listed as qualifying, including PTSD, at their discretion. However, Veterans Affairs doctors are expressly prohibited from recommending patients for enrollment in any state's medical marijuana program. VA General Counsel has advised that completion of a state medical cannabis form is in violation of the Controlled Substances Act and subject to its enforcement provisions. A major reason for this is that the federal government categorizes the substance as a Schedule 1 drug, the most restrictive of five groups. Marijuana, along with other drugs in this category—LSD, heroin, ecstasy, peyote—is considered to have a high potential for abuse and is subject to harsh restrictions on scientific studies. Researchers who want to conduct a study must register with the Drug Enforcement Administration for human trials and get (read “win”) approval from the FDA and the Department of Health and Human Services. The DEA approval allows the researchers to buy the drug from the National Institute on Drug Abuse.

Another reason the VA provides sounds quite anecdotal: there is no solid evidence that cannabinoids are an effective treatment for post-traumatic stress disorder, so there needs to be some more solid research on the topic. So, the VA wants to get evidence without conducting studies.

However, past June, the U.S. House of Representatives and the Senate finally voted to allow doctors in the Department of Veteran Affairs to recommend veterans medical marijuana.

Rest of World Keeps Abreast

While the United States' studies are stalled due to problems with federal approval of using marijuana for testing, scientists all around the world are taking the lead generating medical arguments.

Germany, Spain, and Switzerland are launching medical cannabis programs that are aimed to determine whether the drug may treat PTSD symptoms. Most of these programs are funded by governments.

In March, Canada announced the launch of a cross-country study to investigate the effects of marijuana on patients with PTSD.

The Israel's University of Haifa conducted a study that showed that cannabis administered to rats within 24 hours of suffering a psychological trauma effectively blocked the development of PTSD.

Politics vs. Science

In an ideally organized world, where the scientists work for the good of mankind, the government strongly supports them in all possible (read “legal”) ways. Science supersedes politics there. But in the real world, researchers constantly get stuck in the mire of bureaucracy, biases, and political intrigues.

A few months ago, the New York University's medical school quietly phased out eight studies, one of which was a trial on the effect of marijuana on traumatized veterans. The Food and Drug Administration investigators found that records had been falsified, and the scientists involved had failed to keep accurate case histories. According to the FDA letter, the violations threaten “safety and welfare, and raise concerns about the validity and integrity of the data collected.” At the same time, researchers who were conducting the study said that they took full control of those studies and claimed that none of the participants had been harmed.

MAPS believes that the DEA has long argued that there is no sufficient evidence to support rescheduling cannabis. At the same time, it systematically impeded scientific research thus demonstrating its interest in maintaining the existing drug laws rather than making important drug control decisions based on scientific evidence. Many medical marijuana defenders also argue that the substance should be moved to Schedule III, allowing scientific research to continue. The DEA respond to this by arguing that marijuana continues to meet the criteria for Schedule I because it has a high potential for abuse and “no currently accepted medical use.”

Such position of the federal government discourages scientists from pursuing research needed to test the medical effectiveness of the drug. Scientists say that they are trapped in this vicious circle – it is always a danger if the government acts on certain kinds of persuasions or beliefs rather than evidence.

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