Cave Creek, Arizona—This week, Scottsdale Research Institute (SRI) is requesting that the U.S. Court of Appeals for the District of Columbia Circuit to order the U.S. Attorney General William and the U.S. Drug Enforcement Administration to process its application to cultivate cannabis for its clinical research. SRI’s clinical trials focus on whether medicinal cannabis can treat veterans suffering from otherwise untreatable PTSD.
For decades, DEA has required federally approved researchers like SRI to use cannabis produced by the University of Mississippi. This cannabis, however, is distinctly different from the cannabis found in medical cannabis dispensaries around the country. SRI used it for Phase II trials, and found it was not appropriate for clinical research.
Almost three years ago, SRI applied to grow its own cannabis for clinical research under strict government protocols. Yet, the DEA has ignored repeated requests from SRI and at least seven letters sent by members of Congress from both parties questioning DEA’s delay.
Below are statements from SRI Principal Investigator Dr. Sue Sisley and Matthew Zorn and Shane Pennington of Yetter Coleman LLP, a trial and appellate boutique located in Houston, TX, representing SRI in the matter. SRI’s filing can be found at www.admin.law.
Statement from SRI Principal Investigator Dr. Sue Sisley:
While most states in the U.S. recognize that cannabis has medical value, the DEA says otherwise, pointing to the absence of clinical research. But at the same time, government regulations and bureaucracy prevent researchers like SRI from ever doing the clinical research the DEA has overtly demanded.
It took us seven years to obtain government approval to investigate the safety and efficacy of cannabis to treat veterans with treatment resistant PTSD. And the difficulties in doing the research did not stop there. The only legal source of cannabis in the U.S. for clinical trials comes from the federal government. We used it for our Phase II trials. What we found was that it was wholly inadequate for serious clinical research. It looks nothing like the cannabis that can be found in medical cannabis dispensaries around the country and is so bad that it sabotages the research.
Back in October 2016, we submitted an application to manufacture cannabis for our clinical trials, but the DEA has not responded to our application. In the meantime, SRI and all the other cannabis researchers in the country are forced to continue using this sub-par cannabis, or import it from foreign countries like Canada. We’ve made numerous attempts to urge DEA to move forward on our application and its August 2016 pledge to support cannabis research in the U.S. by licensing other growers for research. Members of Congress from both sides of the aisle have written no fewer than seven letters to the agency asking for updates. We’re still waiting to hear back, and unfortunately, because of this delay, our research stagnates.
We were hopeful that we could put sufficient pressure on the new Attorney General so that the DEA would license new cannabis producers for research before Summer 2019. But there’s been no progress, despite years of lobbying, so we are now seeking a remedy through the courts. We filed an action in the U.S. Court of Appeals based in Washington, D.C. asking the court for an order compelling the DEA to process our application. We hope that this recent filing in the D.C. Circuit encourages the DEA not only to process our application, but to process the applications of others, so that we can all continue to do important research into the safety and efficacy of cannabis for treatment resistant illnesses.
Statement from Yetter Coleman LLP Attorney Matthew C. Zorn:
This is a case about the DEA disregarding the law to delay important research to explore the potential of cannabis to treat our nations’ veterans suffering with treatment resistant PTSD. As we lay out in detail in our filing, there is simply no excuse for the agency’s two-and-a-half year delay in processing SRI’s application to manufacture cannabis for its clinical trials.
Many still do not understand why our federal government continues to place cannabis in a Schedule I classification alongside killers like heroin — a schedule reserved for the most dangerous substances in our society with the highest potential for abuse and no currently accepted medical uses. Our recent filing in the D.C. Circuit explains why.
Statement from Yetter Coleman LLP Shane Pennington:
The DEA routinely says it needs people like Dr. Sisley to do more research before it will recognize cannabis’s medical value. But at the same time, it delays acting on SRI’s application to manufacture medical grade cannabis for its clinical research, and worse, saddles it with low-grade government grown cannabis not fit for clinical research. We hope the D.C. Circuit will see this impossible circumstance the same way and intervene to end the delay so that SRI’s important clinical research can move forward.
Scottsdale Research Institute (SRI) is an Arizona-based clinical trials site that is dedicated to advancing the state of medical care through rigorous research. SRI strives to conduct high quality, controlled scientific studies intended to ascertain the general medical safety and efficacy of smoked and vaporized cannabis flower. For more information on its clinical trials, visit http://www.wecanstudy.org/.
Sue Sisley, MD
President/Principal Investigator, SRI
Yetterman Coleman LLP