Pubdate: Sun, 02 Oct 2011 Source: Washington Post (DC) Copyright: 2011 The Washington Post Company Contact: http://mapinc.org/url/mUgeOPdZ Website: http://www.washingtonpost.com/ Details: http://www.mapinc.org/media/491 Author: Brian Vastag MARIJUANA STUDY OF TRAUMATIZED VETERANS STUCK IN REGULATORY LIMBO Medical marijuana is legal in 16 states and the District of Columbia. But obtaining it from the federal government for research requires surmounting an extra regulatory hurdle that is not required for any other drug. That's because one government agency, the National Institute on Drug Abuse, controls the nation's supply of research marijuana. Any non-government researcher wanting access to it needs to satisfy the special HHS committee. On Sept. 14, Wattenberg, the official in charge of the committee, wrote to Doblin detailing "a number of concerns related to the proposal's approach, feasibility, and documentation of human subjects' protection." But written comments from the five committee members paint a jumbled picture of sometimes contradictory concerns. One member wrote that the study should exclude veterans who have previously smoked marijuana. And another committee member asked for the opposite, that the study should only include people who have smoked the drug, as those naive to it might suffer anxiety or panic attacks. A third reviewer wrote that study participants should be monitored closely - presumably in a hospital - rather than letting them smoke the marijuana at home. "Turning this into an in-patient study ends the study," Doblin said. "Nobody will live in-patient for three months, and that increases the study costs astronomically." Other comments expressed skepticism that the marijuana in the study - given in weekly batches - could be kept from getting "diverted," meaning given or sold to non-participants. In a phone interview, Doblin pointed out that the study's design satisfied FDA drug-diversion officials. Participants will be required to videotape their every interaction with the weed, and will have to return any they do not smoke. In addition, a second person will have to witness the smoking and check in with the researchers weekly. Doblin plans to modify the study and resubmit it to the committee, which will have to unanimously agree before the marijuana sale can move forward, Broido said. But even if HHS approves, another bureaucracy looms - that of the Drug Enforcement Administration. The nation's drug cops also have to approve the research. "It's a long road," Doblin said. "But it's worth it. We're the mythical American trying to play by the rules." Medical marijuana is legal in 16 states and the District of Columbia. But obtaining it from the federal government for research requires surmounting an extra regulatory hurdle that is not required for any other drug. That's because one government agency, the National Institute on Drug Abuse, controls the nation's supply of research marijuana. Any non-government researcher wanting access to it needs to satisfy the special HHS committee. On Sept. 14, Wattenberg, the official in charge of the committee, wrote to Doblin detailing "a number of concerns related to the proposal's approach, feasibility, and documentation of human subjects' protection." But written comments from the five committee members paint a jumbled picture of sometimes contradictory concerns. One member wrote that the study should exclude veterans who have previously smoked marijuana. And another committee member asked for the opposite, that the study should only include people who have smoked the drug, as those naive to it might suffer anxiety or panic attacks. A third reviewer wrote that study participants should be monitored closely - presumably in a hospital - rather than letting them smoke the marijuana at home. "Turning this into an in-patient study ends the study," Doblin said. "Nobody will live in-patient for three months, and that increases the study costs astronomically." Other comments expressed skepticism that the marijuana in the study - given in weekly batches - could be kept from getting "diverted," meaning given or sold to non-participants. In a phone interview, Doblin pointed out that the study's design satisfied FDA drug-diversion officials. Participants will be required to videotape their every interaction with the weed, and will have to return any they do not smoke. In addition, a second person will have to witness the smoking and check in with the researchers weekly. Doblin plans to modify the study and resubmit it to the committee, which will have to unanimously agree before the marijuana sale can move forward, Broido said. But even if HHS approves, another bureaucracy looms - that of the Drug Enforcement Administration. The nation's drug cops also have to approve the research. "It's a long road," Doblin said. "But it's worth it. We're the mythical American trying to play by the rules." - --- MAP posted-by: Jay Bergstrom