Drugs

Psychedelic Science Org's 14-Year Headache of Trying to Buy Pot From the Feds

An FDA-approved PTSD study would be the first federally-sanctioned pot research performed outside the U.S. gov't.

Photo Credit: Mavrick /Shutterstock.com

As a psychiatrist and physician focused on internal medicine, Sue Sisley of Arizona treats first responders and military veterans on a regular basis. Many of them suffer from some form of post-traumatic stress disorder (PTSD). After years observing and speaking with patients she learned that many were using an alternative medicine—cannabis—to successfully manage their symptoms.

“We ran these patients through the gauntlet of every FDA-approved medicine, and either nothing worked or it had really onerous side effects,” said Sisley. “So all these patients were gradually, on their own, starting to use cannabis as an alternative way to treat their symptoms, and talking to me about it.”

While Sisley describes herself as a lifelong Republican who has never tried an illicit drug and doesn’t drink, she became curious to know why and how cannabis was helping so many of her patients.

“This is a dire need, understanding PTSD, not just for combat vets but for all our citizens who are plagued by this,” she said, noting that 22 veterans kill themselves per day in the U.S. according to statistics from the Department of Veterans Affairs. “Any physician who’s also a human being can’t rest when we know that there's something out there, in this case a plant, that has the potential to reduce human suffering.”

She began to look into studying the plant, but came up against the same wall that has blockaded any attempts at clinical research on cannabis outside of limited research by the U.S. government for the last 40 years. Due to the demonization of cannabis by drug war propaganda, the plant falls under Schedule I classification. This is the most restrictive possible scheduling, and means that officially, pot is considered dangerous and devoid of any potential medical use.

“I started asking more and more questions about why we couldn't research this drug properly and why these studies were being suppressed,” she said. “[Cannabis] has proven itself over and over again in literally thousands, millions of patients across the country, and when you know that, you can’t rest and just allow this plant to be forced out. I think we have a duty as physicians to demand that this plant be rigorously studied.”

Her curiosity and determination led her to meet Rick Doblin, the executive director of MAPS (the Multidisciplinary Association for Psychedelic Studies). The California-based nonprofit organization has been trying for 14 years to complete federally sanctioned clinical research studies on cannabis. So far, however, the National Institute on Drug Abuse (NIDA)—which has a DEA-protected monopoly on the only legal supply of cannabis for use in FDA-regulated research—has refused to sell them cannabis.

Doblin and Sisley worked to develop protocols for a study that would look at cannabis’ effects on treatment-resistant combat veterans with PTSD, with Sisley as principal investigator. After years of back and forth, the study’s protocols were approved by the Food and Drug Administration three years ago. They were also approved by the University of Arizona Institutional Review Board (IRB), and the University of Arizona has agreed to play host.

There’s just one problem: they still need NIDA approval in order to purchase federally sanctioned weed, and NIDA won’t sell until a third review process is completed by the U.S. Public Health Service (PHS), as required by a 1999 guideline.

This additional review is not required for research on any other Schedule I drug, but was tacked onto the regular approval requirements and is governed by the U.S. Health and Human services department, under NIDA.

After the original study protocol was rejected by PHS in September 2011, MAPS resubmitted a revised protocol on Oct. 24, 2013. Ever since, the line has gone dead. Unlike FDA protocols which require a response within 30 days, there is no timeline requiring PHS to respond. The PHS guidance has effectively blockaded the study of cannabis by failing to respond.

Sisley called the PHS review process redundant, and said the only real reason for it to exist is to keep the war on drugs alive.

“If their motive is to suppress any research that might prove the benefits of marijuana, then it’s understandable they don't want that data out there because that conflicts with their mission,” she said.

Brad Burge, communications director for MAPS, points out that President Obama has the authority to terminate the extra requirement at any time. The Secretary of Health and Human Services could also legally revoke the guidance as it was issued within HHS.

“We’re hoping with this pressure, with enough public attention, HHS will make a statement or Obama—especially given his recent statements on medical marijuana—will decide to eliminate the hold, and to eliminate the process,” he said.

Thousands of veterans nationwide swear by marijuana’s effectiveness in reducing their PTSD symptoms and advocate for better access to cannabis as an alternative to the pharmaceuticals they’re regularly prescribed. Perry Parks, a Vietnam combat veteran and decorated retired military officer called the limits on access to medical marijuana a "healthcare tragedy few people recognize.” Oaksterdam University has a new scholarship program to help train more veterans to grow their own plants and work in the cannabis industry.

Despite the vocal and increasingly recognized call for veterans' access to cannabis, the study in question would be the world’s first-ever controlled clinical study on using the herb to treat PTSD in human patients. Burge notes that prior animal studies, among them a study using lab rats published in the scientific journal Nature, have shown that cannabis helps calm an overactive fear system.

“If it can be shown that marijuana helps reduce depression and suicidality, which are things we want to explore in the study, then we can save a lot of lives,” he said. “The protocol of the test is for 50 veterans, but the results will apply to people suffering from PTSD from any cause, not just war, but sexual assault, violent crimes, etc.”

Rick Doblin wrote a letter to Sarah Wattenberg of HHS on February 13 requesting a response. In it, he mentions a New York Times op-ed discussing the federal obstruction of medical marijuana research. Doblin observed in the letter that the op-ed fails to mention the PHS protocol review process, “which is the key obstruction along with the NIDA monopoly.”

He continued, “Given the dramatic move in public opinion in support of medical marijuana programs, medical marijuana research, and marijuana legalization, can you help me understand why the Obama Administration still insists on obstructing medical marijuana research?”

Sarah Wattenberg did not respond to Doblin's letter.

AlterNet sent an email to Wattenberg asking when the review process would be completed and who was responsible for reviewing the study. HHS spokesperson Tara J. Broido responded with a blanket overview of the department’s review process, part of which follows:

“The review committee consists of experts from across [HHS] with backgrounds relevant to the research being proposed. This can range from expertise in drug development, to mental health and substance use disorders, to pain management, to alternative medicine. The final decision as to whether or not to approve a proposal is based on the consensus of the experts on the review committee. In addition to the committee approving a study, the researcher must apply for an Investigational New Drug Application (IND) from the FDA and obtain a DEA registration number for Schedule I substances. When all of these are obtained, NIH provides research-grade marijuana for the project on a reimbursable basis.”

Doblin reiterated in an email to AlterNet that MAPS has already obtained an IND from the FDA.

“We have full FDA approval for the protocol as designed,” he said. “The FDA has placed a clinical hold on the study until we provide them with information about the marijuana that we will be using in the study. For now, NIDA is the only source of supply so we need to wait on the PHS review before informing FDA if we can use NIDA marijuana. Then we would try to obtain DEA approval.”

When AlterNet followed up with Broido regarding the timeline for the review, she responded, “The resubmitted application is currently under review by the committee," but did not provide a timeline.

Burge said it’s becoming “increasingly clear” that the PHS requirement is in place solely to block medical marijuana research. He notes that while the government does fund research and provide cannabis for some studies of isolated cannabinoids—for example looking just at THC or studies on synthetic cannabinoids—“they're doing everything they can to prevent any form of research into the benefits of smoked, whole plant marijuana as a potential prescription medicine.”

“It’s becoming increasingly clear the only purpose of this extra review is to obstruct research—why else would there be no time limit?” Burge said. “I see news stories pop up every day about vets using marijuana to treat PTSD. Something tells me this news about actual research being obstructed may come as a surprise to many.”

April M. Short writes and edits for AlterNet. She previously worked as AlterNet's drugs and health editor.