BLOCKING GOOD SCIENCE

Yet Again, the Feds Just Say No to a Clinical Trial Involving
Marijuana by J.M. Smith

When the feds last week blocked a University of Arizona doctor's
attempt to launch the nation's first clinical trial of marijuana to
treat post-traumatic stress disorder, they didn't end anything.

They started it.

"Hopefully, this is just the first round," said Dr. Sue Sisley, an
assistant professor in telemedicine in Phoenix whose study was
rejected by a federal panel despite Food and Drug Administration approval.

Sisley wants to treat 50 vets with PTSD who have not responded to
therapy or other treatments. But the National Institute on Drug Abuse
(NIDA), an arm of the U.S. Department of Health and Human Services,
blocked the effort.

The study was first bridled by the FDA last fall over seemingly minor
problems with the protocol, including how to ensure the pot will be
properly kept. The study's sponsor, the nonprofit Multidisciplinary
Association for Psychedelic Studies (MAPS), and Sisley addressed those
concerns, and the FDA gave its nod.

Then NIDA put the brakes on again with its rejection.

This isn't the first time an FDA-approved clinical trial has been
blocked. Two other MAPS trials were blocked by NIDA; one involving the
use of vaporizers was stalled for more than seven years until it
basically died on the vine.

Veterans often suffer from PTSD, especially those who served in
Vietnam, Iraq and Afghanistan. Estimates of the number of Iraq
veterans who will return with PTSD, which is an anxiety disorder,
range as high as 18 percent. That's a lot of trauma--and a lot of stress.

Many doctors think marijuana might work on PTSD, because there are
cannabinoid receptors in the parts of the brain that control anxiety,
fear and reactions to stress. Pot works--or might work--because the THC
in marijuana binds to those receptors. Better living through modern
chemistry, indeed. It's appalling that the federal government is
blocking good science, designed and executed by qualified physicians
and approved by the FDA.

Sisley and MAPS are on a quest to make pot--the kind you smoke, not the
extracted cannabinoids--a federally approved prescription drug, which
makes perfect sense. It's widely available, cheap and effective
against numerous ailments.

The group also funds research into the use of MDMA, which some of you
know is ecstasy. Nowadays, ecstasy is commonly a street-brewed
concoction of nasty shit you don't want your daughter swallowing at
the rave, because, at the least, she might end up sucking on a
pacifier--or something worse.

Pure MDMA in infrequent doses is useful in several areas of
psychotherapy, however, including for PTSD patients, and the FDA
recognizes its potential. If you want to do a clinical trial using
ecstasy, go for it: The federal government will make some available to
you, because the National Institute on Drug Abuse can't block you.

But NIDA, which was justifiably created to bring science to bear in
the worthy and just fight against substance abuse and addiction,
controls the only federally legal supply of pot for research, so you
basically need the group's permission for a clinical trial.

Good luck with that.

Sisley's Great Scottsdale Pot Test is also linked to a legal case
involving access to marijuana for research. Professor Lyle Craker, a
plant scientist at the University of Massachusetts, sued to break the
NIDA death grip on weed for clinical trials. He wants to grow some for
doctors.

In addition to its monopoly on legal weed, NIDA controls the quality.
They don't have the good stuff, which is really the only thing that
makes sense, since that's what people are smoking in medical-marijuana
states.

It seems the feds are selling researchers schwag. I want my money
back.

It's unlikely that NIDA will ever give the green light to Sisley's
clinical trial, which would use smoked marijuana. The NIDA website
(teens.drugabuse.gov/facts/facts_mj2.php#medical) acknowledges that
cannabinoids prove promising, but the site tells teens "it is unlikely
that smoked marijuana will be developed as a medication because of its
negative health effects."

Hmpf.

Meanwhile, outside of the United States, hundreds of medical-marijuana
and cannabinoid studies have been completed or are under way around
the globe. Read about a few at www.cannabis-med.org/studies/study.php.