Pubdate: Tue, 27 May 2014
Source: Forum, The  (Fargo, ND)
Copyright: 2014 Forum Communications Co.
Contact:  http://www.in-forum.com/
Details: http://www.mapinc.org/media/991
Author: Christopher Snowbeck, St. Paul Pioneer Press, INFORUM
Bookmark: http://www.mapinc.org/find?253 (Cannabis - Medicinal - U.S.)

MEDICAL MARIJUANA STUDIES FACE RED TAPE

MINNEAPOLIS  A year ago, University of Minnesota researchers received 
a $9.5 million grant from the National Institutes of Health to study 
pain in patients with sickle cell disease.

Normally, such an award would quickly launch a study, but lead 
researcher Kalpna Gupta is still waiting on a critical part of the 
research  and moved the work to California to speed the process.

Gupta wants to see whether medical marijuana can treat pain.

Completing such a study involves so much red tape that Gupta has 
decided to collaborate with researchers in San Francisco who have 
experience threading the bureaucratic needle.

"Our grant has been funded for the last year," Gupta said, "and we 
are still waiting."

The problem, researchers say, is a tangle of federal regulations that 
can delay research or prompt scientists to give up on marijuana 
studies altogether. The issue came up repeatedly this spring at the 
state Capitol, as both supporters and opponents of legislation to 
legalize medical marijuana in Minnesota agreed that there's just not 
enough top-notch scientific evidence about how it works for patients.

There are some small signs of improvement, however, including a 
bumper crop of marijuana that's been planted in Mississippi this 
spring specifically for researchers. But access is controlled by the 
National Institute on Drug Abuse.

"NIDA has a mandate from Congress" that its marijuana studies focus 
on preventing drug abuse, said Dr. Donald Abrams, a University of 
California-San Francisco researcher who is collaborating on the 
sickle cell disease research. "You cannot really be funded by NIDA to 
study cannabis as a potential treatment ... hence the lack of research."

Researchers who want marijuana for medical studies must confront 
multiple federal agencies.

They must submit an application to the U.S. Drug Enforcement 
Administration, which seeks advice from the U.S. Department of Health 
and Human Services on the quality of the research proposal. Drug 
development studies typically are approved by the Food and Drug 
Administration, too.

Marijuana is a Schedule I controlled substance, which means it has no 
accepted medical use and a high potential for abuse, according to the 
federal government. So, researchers must obtain a registration to 
work with Schedule I drugs, a classification that includes heroin and LSD.

To obtain marijuana, researchers must turn to the only federally 
approved source: a farm at the University of Mississippi that has had 
contracts with the federal government since 1968. The university's 
Marijuana Project maintains a supply of research-grade cannabis and 
even provides marijuana to a few patients who decades ago 
successfully sued for access.

Research applications for marijuana are handled by NIDA, where agency 
officials say they have supported a limited number of studies over 
the years touching on medical aspects of marijuana. Even so, the 
agency acknowledged in a statement that its focus is "solving the 
devastating problem of drug addiction and related health conditions."

"We are experts on addiction and drug abuse," the agency said. "We do 
not do research into treatment for epilepsy, PTSD (post-traumatic 
stress disorder), glaucoma, cancer or many other problems and 
conditions that have been possible targets for medicinal marijuana."

At the state Capitol this spring, patients pushing for access to 
medical marijuana said they were well aware of the lack of research.

The most powerful force for legalization came from parents of 
children with seizure disorders who provided anecdotal evidence about 
the effectiveness of marijuana provided in a liquid form. In this 
version, the psychoactive components of marijuana are minimized, and 
children receive a greater concentration of a compound called 
cannabidiol, or CBD.

Jessica Hauser of Woodbury, Minn., said that as she started to hear 
stories about medical marijuana, she wondered: "Where's the research 
if it's so great?" But after talking with parents of children treated 
in other states, Hauser became convinced that she wanted her son 
Wyatt to have access.

"There are a lot of bureaucratic problems at the federal level that 
make it incredibly difficult for doctors to do the research they 
need," Hauser said.

Research Wrangling

Minnesota lawmakers this month passed a bill that would provide 
terminally ill patients and those with any of eight serious medical 
conditions access to medical marijuana from two state-regulated 
manufacturers. Physicians would have to certify that a patient has a 
qualifying condition and agree to submit information so the Minnesota 
Department of Health could maintain a research registry on patient outcomes.

Gov. Mark Dayton has not yet signed the legislation but pledged to do so.

The research registry might help some patients, but it won't provide 
the sort of scientific data on medical marijuana that many physicians 
are looking for, argued Dr. Sue Sisley, a psychiatrist at the 
University of Arizona.

In 2009, Sisley started working with reviewers at the FDA on a 
proposal to study medical marijuana for veterans with PTSD. Approval 
came in 2011. Then it took another three years for a different 
federal health agency to approve the study, said Sisley, who twice 
testified this spring at the state Capitol.

Sisley still must work with the DEA to obtain a Schedule I 
registration. There's now a hang-up, she said, in obtaining the sort 
of marijuana she needs from the federal government's marijuana farm.

DEA officials say that 236 investigators were registered to study 
marijuana as of May 1, and the number has held steady for the past 
several years. The agency says it has not denied registration to an 
HHS-approved marijuana study in more than 20 years.

"Complete applications (for registration) take about five months to 
approve," the agency said in a statement.

But Gupta of the University of Minnesota said she spent six months 
just trying to fill out her application for a Schedule I registration 
and ultimately gave up.

"I would call, and they would not call back," Gupta said. "I was so 
surprised  I couldn't believe it."

In the end, the sickle cell study required approvals from eight 
regulatory agencies, said Abrams, the researcher in California.

"You have eight different people reviewing it, and everybody wants to 
make a change," he said in an interview.

Growing movement

There Are Signs the Research Environment Could Be Improving.

Earlier this month, GW Pharmaceuticals of Britain announced FDA 
approval to study whether a medication with cannabidiol, or CBD, 
might help children with Dravet syndrome, a rare and catastrophic 
form of childhood epilepsy. The company also is studying in the U.S. 
whether medication containing marijuana compounds can help patients 
suffering from cancer pain and spasticity with multiple sclerosis.

"We have conducted, or will conduct, trials at more than 50 sites in 
the U.S.," company spokesman Mark Rogerson wrote in an email. "So, it 
is perfectly possible for a pharmaceutical company to go through the 
process  it just takes more time."
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MAP posted-by: Jay Bergstrom