Souce: Wired.com/Danger RoomKatie Drummond
An Arizona psychiatrist is tantalizingly close to federal approval
for a groundbreaking study of marijuana’s potency in treating PTSD — if
only the National Institute on Drug Abuse would stop stonewalling her.
Dr. Sue Sisley, an assistant professor of psychiatry at the
University of Arizona College of Medicine and a psychiatrist whose
practice treats mostly war veterans, wants to add evidence-based science
to the ubiquitous anecdotal reports, not to mention animal research,
that point to marijuana’s effectiveness at quelling symptoms of
post-traumatic stress. Although plenty of vets smoke up, medical
marijuana can only be prescribed to PTSD sufferers living in New Mexico —
where 27 percent of those with an approved ID card suffer from PTSD,
making it the state’s number one qualifying diagnosis — and nary a study
has evaluated whether the illicit drug actually works.
“Plenty of the veterans I’ve treated use marijuana, only they usually
buy it illegally and use it covertly,” Sisley told Danger Room. “With
research, we can actually figure out which symptoms it might help with,
and what an optimal dosing strategy might look like.”
With PTSD afflicting as many as 37 percent
of this generation’s Iraq and Afghanistan vets, and no fail-proof
treatment available, the Pentagon’s already turned an eye to
unconventional research. Military docs look into everything from brain rebooting to neck injections.
But they’ve yet to offer anybody a joint, and Sisley’s efforts are now
at a standstill: After months of back-and-forth, federal regulators just
won’t give her proposal the green light.
“At this point, I can’t help but think they simply don’t want to move
forward,” she said. “Maybe they figure if they stall long enough, we’ll
give up and go away.”
Sisley’s study would be triple-blind and placebo-controlled, meaning
none of the researchers or veterans would know who’s getting high and
who isn’t. She plans to evaluate 50 veterans, all of whom would spend 30
days marijuana-free before participation. For two two-month stretches,
they’d be asked to either smoke or vaporize a maximum of 1.8 grams a
day, and would be given weekly supplies of various strains of marijuana
with THC levels ranging from 0 percent to 12 percent.
Of course, Sisley acknowledges that it’s a study with potential for
abuse. (Cheech and Chong marathon, anyone?) That’s why participants will
be given small supplies of the drug, asked to videotape each smoking
session and return any leftover weed.
“If we get a chance to do this, we’re not taking liberties,” she
said. “This is a carefully controlled, rigorous scientific study. We’re
not sitting around trying to get these vets high.”
And already, Sisley and her sponsor, the Multidisciplinary
Association for Psychedelic Studies (MAPS) — a non-profit that advocates
for medical research of banned substances, and is currently sponsoring a
study on ecstasy as a PTSD treatment
— have made significant progress in getting the study approved. Earlier
this year, the FDA okayed their research proposal, after which it was
sent to a panel of five reviewers at the National Institute on Drug
Abuse (NIDA) and the Public Health Service (PHS).
Marijuana is the only controlled substance whose use in research
needs to be approved by the NIDA. The federal agency has a monopoly on
supplies of research weed, so aspiring investigators need the NIDA’s
approval before they can legally buy the stuff. But after four months of
evaluation, the panelists in September rejected the proposal,
citing, among other factors, Sisley’s lack of experience in treating
veterans with PTSD and concerns over patients using such a substance
associated with “a number of safety issues” outside a medical facility.
And in order to move forward with funding, the panelists need to
reach unanimous approval. But they’re all over the map when it comes to
Sisley’s study. In the rejection document, one panelist noted that
researchers should only “perform the study in marijuana naive subjects.”
Another advised using an “experienced population.” All that incoherence
makes Rick Doblin, the executive director of MAPS, fear for Sisley’s
proposal.
“They’re making absolutely contradictory statements,” he told Danger
Room. “Not to mention that we’re asking for marijuana from an agency
designed to prevent people from using marijuana. There’s something
fundamental that just doesn’t work here.”
NIDA didn’t respond to requests for comment. But a spokesperson helpfully informed the Washington Post
that “the production and distribution of marijuana for clinical
research is carefully restricted under a number of federal laws and
international commitments.”
Sisley might not have the health officials on her side, but she is
catching the eye of some Veteran’s Affairs staff members. Several have
offered to (quietly) refer patients for the study, and two VA doctors in
Phoenix — Dr. Deb Gilman and Dr. Lauren Lee, both with significant
experience treating PTSD — have signed on as co-investigators to help
Sisley’s proposal pass NIDA muster.
“The doctors I know think this war on marijuana is awful, and they’re
tired of being in the middle of it,” Sisley said. “They just want to do
real research, or read real research, and not operate around all of
these agendas.”
As Sisley prepares to tweak and re-submit her proposal, Doblin and
MAPS are busy trying to break up NIDA’s marijuana monopoly. They’re
stuck in an ongoing lawsuit with the DEA, after the agency in 2001 rejected MAPS’ proposal to build their own medical-marijuana growing facility.
And potential study participants — Sisley has heard from hundreds of
interested vets — might be wise to hope the MAPS lawsuit works out
before the study is okayed. Turns out, NIDA’s pot kinda sucks anyway.
“At one point, years and years ago, they were selling it to
researchers for $7 a gram, which is not a bad price,” Doblin said. “But
really, it’s terrible quality.”
