Friday 2 August 2019

Scottsdale researcher sues U.S. government over quality of marijuana for studies



Sue Sisley
 Sue Sisley

A federally-licensed marijuana researcher is suing the government agency that grants her a license to conduct research.

Dr. Sue Sisley has asked the District of Columbia Circuit of the United States Court of Appeals to compel the U.S. Drug Enforcement Agency to allow researchers to use cannabis from sources other than the feds, thereby ending the government’s monopoly on manufacturing the plant for studies.

“Simply put, this cannabis is sub-par,” Sisley’s attorney, Shane Pennington, wrote in the complaint filed in court.

Sisley a few months ago completed her research on the effects of marijuana for veterans with Post Traumatic Stress Disorder, but the results have yet to be published. The DEA had approved that study – the first time the agency has done so for this kind of research.

She said her suit, which she filed in June, is finally getting some traction.

“Groups are offering to submit amicus briefs … we are in good shape to succeed here,” she said, adding that her lawyers even took the case pro bono.

Under the Controlled Substances Act, anyone seeking to manufacture and distribute marijuana must apply to the DEA, but Sisley said for almost 50 years, the only legal source of cannabis for research comes from the University of Mississippi, which she has openly complained about before. Sisley said she just wants the DEA to follow through on its pledge to end the cannabis monopoly at Ole Miss.

“When they announced that [pledge], they were announcing other growers they invited applications in to become a DEA Schedule 1 bulk manufacturer,” she said.

Sisley said she applied to be one about three years ago, but her application has just been sitting there, even though the DEA accepted her application fee.

“My attorneys think it’s unlawful and maybe even unconstitutional,” Sisley said.

She noted that Congress amended the Controlled Substances Act to require the U.S. Attorney General to publish a notice of application no later than 90 days upon receiving an application to manufacture a Schedule I drug, and argued that the DEA is violating the law. But she doesn’t even blame the DEA, speculating that it goes much higher than them.

“We are also suing the Attorney General, not just the DEA because my gut tells me that the DEA is not responsible for impeding this,” she said.

Sisley also said that her research company, Scottsdale Research Institute, has a “great relationship with the DEA.”

“The local office here has been wonderful to work with. They’re very supportive of our work and I’ve never gotten the impression they were ever trying to block anything,” Sisley said.

It’s the national office that has to deal with federal politics, she said.

Sisley said she is not even asking the DEA to accept her application, just to process it, which she believes would open up processing for the other 30 or so applications also sitting there.

She argued that the cannabis Mississippi uses is “suboptimal.”

“Scientists need access to options and we are handcuffed by a government-enforced monopoly that has only allowed me to study this really suboptimal study drug from Mississippi,” she said, claiming the drug provided for studies is moldy, and contains sticks and seeds.

“They are providing this standardized green powder that is just cannabis ground up,” she said, adding that it also is not being tested like it should.

She says by grinding it up into this powder substance is an “overzealous effort to standardize the study drug batches for clinical trials” and the most optimal substance would just be the marijuana flower.

But right now, Sisley says the efficacy research has been systematically impeded by the government ever since the monopoly was put in place and that it’s the final barrier to cannabis research.

“If we don’t end this monopoly and license other growers, we will continue to see cannabis research sabotaged by this low quality study drug, and we will never be able to do real world studies,” Sisley said.

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