September 29, 2011
Blocking Good Science
By: J.M. Smith
The National Institute on Drug Abuse (NIDA) has continued its trend of blocking FDA-reviewed clinical trials proposed by MAPS. The article compares the relative difficulty of conducting federally-approved research on psychedelics with studies of marijuana, and points out the unlikelihood of NIDA agreeing to let the study move forward.
Originally appearing here.
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.”
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 http://www.cannabis-med.org/studies/study.php.
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