Feds Block FDA-Approved PTSD-Marijuana Research

A study on marijuana’s effects on treating patients with post-traumatic stress disorder has been approved, but it can’t go forward without the marijuana that it needs from a federal agency.

Jake Dimmock, co-owner of the Northwest Patient Resource Center medical marijuana dispensary, works on balancing the pH level of the soil used to grow new medical marijuana plants, Wednesday, Nov. 7, 2012, in Seattle. (AP Photo/Ted S. Warren)

Jake Dimmock, co-owner of the Northwest Patient Resource Center medical marijuana dispensary, works on balancing the pH level of the soil used to grow new medical marijuana plants, Wednesday, Nov. 7, 2012, in Seattle. (AP Photo/Ted S. Warren)

Almost four months after the U.S. Food and Drug Administration and the University of Arizona Institutional Review Board approved a study on how marijuana could be used to help treat veterans experiencing post-traumatic stress disorder, researchers are still waiting for the federal government to sign off on the study and allow them to purchase marijuana.

Proposed by the non-profit organization Multidisciplinary Association for Psychedelic Studies, the study would examine the safety and efficacy of smoked and vaporized marijuana for 50 U.S. veterans with chronic, treatment-resistant PTSD.

Since the U.S. Public Health Service is not allowing researchers to buy any marijuana from the federal government to conduct the study, the research is currently on hold. Technically, the agency hasn’t outright refused to sell marijuana to the researchers for the study, as the PHS is not required to respond to inquiries within a certain number of days.

The FDA, on the other hand, must respond to inquiries within 30 days. Until the PHS decides to respond — which could be never — this potentially life-saving research is on hold.

For years, medical marijuana legalization advocates have argued that the drug can be used to help persons suffering from PTSD-related symptoms such as haunting nightmares and sleeplessness, but they have no scientific evidence to back up their empirical claims.

While animal studies have found marijuana helps “quiet an overactive fear system,” there have been few, if any, controlled clinical studies examining marijuana’s effectiveness in helping human PTSD patients, which is why so many applauded the FDA’s decision to approve this study.

According to MAPS, marijuana is the only drug in the United States that has to be reviewed by the PHS before research can occur, saying the National Institute on Drug Abuse “has a Drug Enforcement Administration-protected monopoly” on the supply of marijuana that can be legally used in FDA-regulated research.

In other words, although the government has a supply of marijuana that has been specifically set aside for research purposes, the NIDA and DEA require that extra review be given to those who are requesting to study marijuana and its effects — a mandate that is not required for any other drug, including those that, like marijuana, have been classified as a Schedule I substance such as MDMA, LSD or psilocybin.

“This groundbreaking research could assist doctors in how to recommend treatment for PTSD patients who have been unresponsive to traditional therapies,” said Rick Doblin, Ph.D., executive director at MAPS. He encouraged the PHS to allow the researchers to obtain the substance.

“If the PHS review requirement was removed,” added Dr. Sue Sisley, who would lead the study, “we would gather information that could help veterans today. The stifling of medical research on marijuana stands in the way of our vets returning to a normal life.”

 

A cure for PTSD in THC?

Though it’s sometimes viewed as a lesser medical condition than other illnesses such as cancer, PTSD is considered a life-threatening illness, since those who suffer from it are at an increased risk of becoming homeless, more likely to abuse drugs and alcohol, and more likely to commit suicide.

It’s estimated that PTSD currently affects about 600,000 veterans, or 40 percent of all returning U.S. soldiers.

The effects of PTSD last for years, and according to R. Andrew Sewell, a professor of psychiatry at Yale University, marijuana can help those who suffer from PTSD with “extinction learning,” which is when positive information outweighs the negative fears that came about as a result of a traumatic experience.

Sewell conducted a study early last year examining whether exposure to THC, marijuana’s psychoactive ingredient, would help those suffering from PTSD as they went through “exposure therapy” — a treatment Sewell believes to be the most effective for treating the medical condition.

Many people who suffer from PTSD find exposure therapy to be a painful process because they have to revisit traumatic memories on a consistent basis. Sewell studied whether THC would help PTSD patients through this process.

What he found was that veterans injected with 1 milligram of THC were calmed down enough to realize that a negative experience may not occur again.

Dr. Raphael Mechoulam, an Israeli neuroscientist credited with discovering THC, agrees that marijuana has properties that could help heal neurological and psychiatric conditions such as Alzheimer’s and Parkinson’s disease, in addition to PTSD.

Mechoulam, also a senior advisor to the Israeli government on marijuana policy and the ethics of research with human subjects, said that “the use of cannabis and THC to treat PTSD in humans appears to provide symptomological (sic) relief at best,” and he sees no reason why the drug isn’t already being used for PTSD.

“In and of itself, there is nothing wrong with symptomological relief,” Mechoulam said. “That’s what taking aspirin for a headache, a diuretic for high blood pressure, opiates to control severe pain, or olanzapine for rapid-cycling mania is all about. We do have the potential, however, to do better than just treating symptoms of PTSD via activation of the cannabinoid receptors.”

He continued, explaining that with the right combination of extinction/habituation therapy and “judicious administration” of drugs such as marijuana, there is a potential to actually cure many cases of PTSD.

 

Turning a blind-eye to marijuana’s healing power

“In light of all evidence currently available, it is striking that the FDA refuses to investigate cannabinoids for the treatment of anxiety disorders like PTSD,” Mechoulam said, “yet (the federal government has) approved studies of MDMA, the club drug Ecstasy, for the treatment of PTSD.”

He pointed out that modern Western medicine currently uses substances that are widely known to be dangerous to use and carry a high rate of abuse, yet doctors still prescribe these drugs because they assume there is some medicinal value.

“With the lives and well being of so many veterans AND private citizens at stake, those in the scientific community and police makers alike cannot afford to miss the wake up call,” he said. “Even a child should be able to see the hypocrisy evident in the relative policies concerning cannabinoids and opiates. It is time to fix this appalling imbalance in our policies concerning the pharmacopia (sic) or else be the laughing stock of future generations.”

Russ Belville, host of the Russ Belville Show and a contributor to High Times, agrees with Mechoulam that the government needs to study marijuana, and pointed out in an article in November that while the government has refused to legalize or allow the use of medical marijuana, the FDA continues to approve painkillers that have been proven to be dangerously addictive and highly abused.

Belville pointed to the recently approved painkiller called Zohydro, which he says contains 10 times the opioid hydrocodone found in Vicodin, a highly abused painkiller, and is not cut with acetaminophen or ibuprofen — additives that are used to prevent users from “crushing and snorting or shooting the drug.”

Another facet of this drug that caught Belville’s eye is that this new “Super-Vicodin” is made by the pharmaceutical company Alkermes, and is intended for use in treating opioid addictions. As Belville noted, Alkermes financially supports the American Society of Addiction Medicine, or “Big Rehab.”

Though the DEA is completely aware of the increased use and abuse of drugs such as heroin, which is often sparked by a painkiller addiction, the DEA said it is allowing the increased production of pain pills to ensure there is “enough left for legitimate patients.”

If the federal government’s hands are not only tied by the money it’s earning law enforcement officials with the war on drugs, but also by pharmaceutical companies who have an interest pushing both their drugs and their rehab programs, it’s likely that breakthrough studies like this one will continue to be put on the back burner.

In the meantime, MAPS says it will continue to pursue its decade-long lawsuit against the DEA, hoping to establish a marijuana-growing facility for FDA-approved research, which the group says would put an end to the National Institute on Drug Abuse’s marijuana monopoly.