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."