July 23, 2014
Study Head Threatens To Pull Funding Over Firings
By: Howard Fischer Capitol Media Services
AZ Daily Sun
AZ Daily Sun writes about the University of Arizona’s firing of marijuana researcher Dr. Sue Sisley and the possibility that MAPS and Sisley will find an alternative location for their FDA-approved clinical study for PTSD in veterans. The article provides an overview of obstacles standing in the way of clinical research into the benefits of marijuana, and interviews MAPS Executive Director Rick Doblin about the future of the study. “So long as the university obtains all the necessary approvals to comply with state and federal law and regulatory requirements, there is no policy in place that would preclude a different state university from conducting this research,” explains Katie Paquet of the Arizona Board of Regents.
Originally appearing here.
The head of the organization offering to fund a study on medical marijuana at the University of Arizona said he will pull the cash unless the school restores fired doctor and researcher Sue Sisley to the staff and the project.
Rick Doblin told Capitol Media Services Tuesday he rejected offers by UA officials to have someone other than Sisley named as “principal investigator” for the study on whether marijuana is useful for patients with post-traumatic stress disorder. Doblin, executive director of the Multidisciplinary Association for Psychedelic Studies, said his group has four years of history with Sisley and will move its funding wherever she goes.
The UA is apparently unwilling to budge, however.
Two top officials at the school’s College of Medicine sent a letter to Sisley earlier this month saying that her services are no longer needed. They said the telemedicine program she headed has made a “strategic decision” to change its focus and therefore she will no longer be needed.
But university spokesman George Humphrey said the school remains hopeful MAPS will decide to keep the study at the university, but with someone else at the helm.
That, said Doblin, is not going to happen.
He said the UA is free to craft — and finance — its own study if it wants.
“We would be glad to help them since the more data on marijuana for PTSD in veterans, the better,” Doblin said. But Doblin said he doubts that will happen since it would require the school to start over again from scratch to get all the federal approvals that Sisley, through MAPS, already has obtained.
At this point, Doblin said the study is looking for a new home. And he said Sisley already has been approached by schools in other states.
But Doblin said he remains hopeful the work can continue in Arizona — albeit not at the UA.
He said a request is being made of the Board of Regents to allow the research to be conducted at either Arizona State University or Northern Arizona University. Doblin said that’s because Sisley, who graduated from the UA and lives in Phoenix, would prefer not to leave the state.
That may be an option — if either of the schools is interested.
“So long as the university obtains all the necessary approvals to comply with state and federal law and regulatory requirements, there is no policy in place that would preclude a different state university from conducting this research,” said regents spokeswoman Katie Paquet.
But Doblin, whose nonprofit organization is involved with other research projects like the use of LSD to deal with anxiety and ibogaine to treat addiction, said even if a plan to transfer the research to ASU or NAU goes nowhere, that does not mean packing up the entire project and moving it out of Arizona.
“We don’t need an affiliation with an academic institution,” he said, pointing out that MAPS itself has been approved by federal officials as the official institution. “We could conceivably do the study out of Sue’s office.”
Well, not exactly her current one.
Sisley, who has a private telemedicine practice — she says she sees about 20 patients a day via video — operates from her own home. Sisley said she would have to get a secure office before the feds allow her to obtain marijuana.
Her study has been four years in the making, much of that because the federal government classifies marijuana as a Schedule 1 drug, one for which there is no legitimate medical use. But MAPS and Sisley have successfully navigated the process, getting the blessing of not only federal agencies but the UA’s own Institutional Review Board which had to approve the protocols because the research involves using human subjects.
And in March, the federal Public Health Service gave its first-of-its-kind approval to studying medical benefits of marijuana.
Aside from the dust-up with the UA, Doblin said a couple of hurdles remain. One is that the project still needs permission from the U.S. Drug Enforcement Agency.
Doblin said DEA is concerned about where the research will take place to ensure that the drugs remain secure. That has been one of the advantages of a university campus.
The other hurdle is funding.
According to Doblin, the study has a budget of $876,000. He said that, to date, MAPS has received specific grants earmarked for Sisley’s work of only $19,000.
But Doblin said he already has been in contact with others interested in financing PTSD research, including the state of Colorado. And he said that, even without dedicated dollars for Sisley, MAPS has more than enough in its own coffers for the project.
The decision by MAPS to yank its sponsorship should come as no surprise to the university. Doblin told UA officials as much in a July 11 letter.
“But for the efforts of Dr. Sue Sisley over more than a four year period, this research would not even exist and would not have been approved by the Food and Drug Administration, the University of Arizona Institutional Review Board, and the Public Health Service / National Institute on Drug Abuse,” he wrote to Caroline Garcia, the school’s associate vice president for research. And he said that Sisley also was “instrumental” in obtaining a multi-year grant from the state Department of Health Services to educate doctors in Arizona about the use of medical marijuana, “a valuable project that will end prematurely with her termination from the university.”
The university, however, has a different take on that.
In their July 9 letter to Sisley explaining why her services are no longer needed, Stuart Flynn, the dean of the College of Medicine, and Joe Garcia, the school’s senior vice president for health sciences, said the university “expects the completion of this contract by mid-September.”
“With its completion, your participation in this program no longer would be (financially) supported,’ they wrote.
Sisley contends there likely is a political component to the UA’s decision not to renew her contracts: She got into a very public dispute with Sen. Kimberly Yee, R-Phoenix, who earlier this year killed a House-passed bill that would have opened the door to using fees paid by medical marijuana patients to finance the research.
Sisley’s plan is for “randomized control tests” using about 70 patients who suffer from PTSD. Participants will get varying doses ranging from a placebo to marijuana with 12 percent THC, the psychoactive ingredient in the plant.
There also will be research comparing the results of those who smoke the drug with those who inhale it as a vapor.
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