Pubdate: Wed, 23 Jul 2014
Source: Capital, The (MD)
Copyright: 2014, Capital Gazette Communications, Inc.
Author: Howard Fischer


Medicinal marijuana Medicinal marijuana [Tribune file] 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

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,

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 are
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 which 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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MAP posted-by: Matt