Cancellation of only active medical marijuana study a blow to researchers

Politics brings down medical marijuana study

WASHINGTON, D.C. - Medical cannabis use is recognized legally in almost half of the states, yet getting approval to study the health benefits of the drug is harder than getting a medical marijuana license.

So it was a big deal last spring when a doctor at the University of Arizona won rare federal approval to test marijuana’s effects on veterans with PTSD.  For marijuana advocates, who believe the research is a key step in getting medical and scientific regulation of the drug— it was a historical shift.

Now three months later, that momentum has come to a crashing halt. 

Over the last two decades, only 15 people have received approval to conduct federal research on marijuana. Dr. Sue Sisley is the only academic to date to receive the green light.

She is also the last person you’d expect to advocate for medical marijuana use. She is a life-long conservative from Phoenix, Ariz., and an established physician who used to work at a family practice with her mother. 

Working with veterans for 15 years, she often turned a blind-eye when they confided in her that they were forgoing their prescribed anti-depressants for something more herbal. But after listening to them for a decade, Sisley said she couldn’t ignore what veterans were telling her and began to think that maybe marijuana really could be the cure for PTSD.

“I got rid of my own prejudices. I am the opposite of this drug culture and yet even I could not ignore what they were disclosing to me in these private sessions,” Sisley told DecodeDC. “They were successfully using marijuana to deal with their PTSD.”

Sisley wanted to test her hypothesis with a randomized trial of marijuana’s effect on 70 veterans with diagnosed PTSD. But the road to federal approval of the study was anything but streamlined.

Faced with numerous hurdles, it took Sisley three years to win the right to start testing. First Sisley got her research plan approved by the FDA, then the U.S. Department of Health and Human Services and finally the National Institute on Drug Abuse (NIDA). Approval of her research made Sisley eligible to use governmentally-approved marijuana to start her research.

After Sisley got authorization, all she needed next was the marijuana itself, a lab at the University of Arizona to begin her study and a final sign-off by the Drug Enforcement Administration. Then she hit her first roadblock.

NIDA—the only institution federally allowed to grow research grade marijuana, at the University of Mississippi—was out of cannabis. They told Sisley she’d have to wait till next year.

“My opinion is that there is a systematic interference, a deliberate attempt to interfere with the progress of marijuana research in the country,” Sisley said. The federal government isn’t as strict with studies that aim to measure the negative impacts of marijuana use, says Sisley, but when the study dares to test some of the potential positives—“you get put into this permanent review process that goes on forever.”

Then politics got in the way. Local government funding meant for the program was canceled after a state senator challenged using the money for Sisley’s research. After Sisley argued against the de-funding of her program, pressure from state government ultimately led to her dismissal from the University of Arizona, according to Sisley. The university disputes political pressure led to her firing. Sisley's study never got off the ground.

“We designed the study to look at vets because we knew that politically it would be hard for the government to reject because of the enormous number of vets who come back each year with PTSD,” Sisley said. “All I care about is helping our vets and doing quality science and I don’t understand why this research is being blocked at any turn, including from the University.”

The outcome isn’t shocking to those in the marijuana industry, who have struggled to gain national legitimacy since the first state legalized cannabis in 1998. Although 23 states legally acknowledge that marijuana has medical benefits, and nine out of 10 Americans say they support medicinal use of the drug. But cannabis isn’t considered medicinal at all on the federal level.

The Drug Enforcement Administration classifies marijuana as a Schedule I drug, which means, at least according to the federal government, it has no “currently accepted medical use and a high potential for abuse.” Therefore, requesting to study the health value of a schedule I substance challenges the very essence of its DEA classification.  Sisley’s research may have been for the good of desperate veterans, but it also openly challenged the government’s position.

“Science is not driving public policy when it comes to various controlled substances,” said Paul Armentano, deputy director at the National Organization for the Reform of Marijuana Laws.

Although federally approved controlled clinical trials of marijuana or its active compounds are rare—only about 120 have ever been approved worldwide-- Armentano says there are thousands of documented observational and pre-clinical trials that have shown positive uses for the drug. But their findings aren’t “discussed in the on-going debate.”

“None of that has caused Congress to even revisit the issue,” Armentano said. “Now we have comparatively more science in regard to marijuana than we have most other drugs, yet Congress has chosen to not even revisit the issue of marijuana’s classification.”

But for Sisley, the set-back to her study also means a setback for the veteran population who are desperate for help.

“People were really benefiting from this plant… so why is the government keeping this plant on the shelf and not letting it be studied in a rigorous way?” she said. “This is such a blow to scientific freedom.”

(Update-- 7-20-14) 

According to a University of Arizona spokesperson, the university will propose a new principal investigator for the study to the research sponsor. It  has not cancelled the study originally lead by Dr. Sisley and holds the right to continue the research without her. It would not comment on why she was let go.

Sisley told DecodeDC she plans to fight the university's plan to replace her with litigation.

 

Print this article Back to Top

Comments

or Subscribe now so you can share your opinion! It’s only a penny for a month trial.