Pubdate: Sat, 22 Mar 2014
Source: Washington Post (DC)
Copyright: 2014 The Washington Post Company
Contact: http://mapinc.org/url/mUgeOPdZ
Website: http://www.washingtonpost.com/
Details: http://www.mapinc.org/media/491
Author: Ariana Eunjung Cha
Page: A1

RESEARCHERS DECRY POLITICS OF MARIJUANA

Millions of ordinary Americans are able to walk into a marijuana
dispensary and purchase bags of pot on the spot for a variety of
medical ailments. But if you're a researcher like Sue Sisley, a
psychiatrist who studies posttraumatic stress disorder, getting access
to the drug isn't nearly so easy.

That's because the federal government has a virtual monopoly on
growing and cultivating marijuana for scientific research, and getting
access to the drug requires three separate levels of approval.

Sisley's fight to get samples for her study - now in its fourth month
- - illuminates the complex politics of marijuana in the United States.

While 20 states and the District have made medical marijuana legal -
in Colorado and Washington state the drug is also legal for
recreational use - it remains among the most tightly controlled
substances under federal law. For scientists, that means extra steps
to obtain, transport and secure the drug - delays they say can slow
down their research by months or even years. The barriers exist
despite the fact that the number of people using marijuana legally for
medical reasons is estimated at more than 1 million.

Stalled for decades because of the stigma associated with the drug,
lack of funding and legal issues, research into marijuana's potential
for treating diseases is drawing renewed interest. Recent studies and
anecdotal stories have provided hope that marijuana, or some
components of the plant, may have diverse applications, such as
treating cancer, HIV and Alzheimer's disease.

But scientists say they are frustrated that the federal government has
not made any efforts to speed the process of research. Over the years,
the Drug Enforcement Agency has turned down several petitions to
reclassify cannabis, reiterating its position that marijuana has no
accepted medical use and remains a dangerous drug. The DEA has said
that there is a lack of safety data and that the drug has a high
potential for abuse.

Sisley's study got the green light from the Food and Drug
Administration in 2011, and for most studies, that would have been
enough. But because the study is about marijuana, Sisley faced two
additional hurdles.

First, she had to apply to the Department of Health and Human Services
to purchase research-grade samples from the one farm in the United
States - housed at the University of Mississippi and managed by the
National Institute on Drug Abuse - that is allowed to grow marijuana
under federal law. HHS initially denied her application but then
approved a revised version March 14 - more than four months after it
was submitted.

Now, Sisley must get permission from the DEA to possess and transport
the drug.

Spokeswoman Dawn Dearden said that the agency is supportive of medical
research on marijuana but needs to follow regulations under the
Controlled Substances Act. "DEA has not denied DEA registration to a
HHS-approved marijuana study in the last 20-plus years," she said.

Sisley, who began her work with PTSD while at the Department of
Veterans Affairs and now works at the University of Arizona College of
Medicine, says she considers the HHS news a "triumph" for marijuana
research. But she says the study has "a potentially long road with the
DEA who is famous for delays."

"There is a desperate need for this research, but it's impossible to
study this drug properly in an atmosphere of prohibition," she said.

Orrin Devinsky, director of the epilepsy center at New York
University's Langone Medical Center, said many would-be marijuana
researchers are driven to abandon projects after they discover how
time-consuming and expensive it can be to obtain the drug.

"There is no rationale for this except for the federal government's
outdated 1930s view about marijuana," said Devinsky, who is studying
the use of an extract for the control of seizures.

A resurgence in research

The cannabis plant was once a staple in American pharmacies, but since
the turn of the 20th century, some states began to see it as a poison
and introduced restrictions. Research on its medicinal uses came to a
virtual standstill.

There are 156 active researchers who are approved by the DEA to study
marijuana - a number that has remained steady in recent years - but
scientists say most are government-funded and focus on the ill effects
of smoking marijuana rather than on potential medicines.

That's poised to radically change. As an increasing number of states
have legalized the use of medical marijuana, a bustling industry of
start-up drug companies and medical groups focused on finding
marijuana-based treatments has emerged. GW Pharmaceuticals, a British
company, is studying two different extracts of marijuana that have
shown promise for patients with Type 2 diabetes and epilepsy. ISA
Scientific, based in Utah, is researching medications for pain and
diabetes made from the cannabinoids found in marijuana that could be
swallowed in capsule form.

Some of these new-generation researchers are exploring ways to try to
speed up their work by bypassing the federal process for obtaining the
drug. In Colorado, for instance, academic researchers have asked state
officials whether they would allow them to study extracts grown within
the state. In Georgia, scientists are seeking legislative action to
allow the state's five medical research universities to cultivate
marijuana. A bill allowing them to do so recently won the backing of a
House committee.

Much of the debate surrounding marijuana research is focused on its
classification by the DEA as a Schedule I drug, the most restrictive
of five categories. Schedule I drugs are considered to have a high
potential for abuse and no accepted medical use. Other drugs in that
group include LSD, heroin and ecstasy.

The American Medical Association said in November that it does not
support state medical marijuana efforts and still considers the drug
dangerous. But it also called on the government to encourage more
clinical research - by reconsidering its classification as a Schedule
I drug. A lower-level classification would allow researchers to obtain
marijuana more easily.

The fact that the Obama administration in recent months has moved to
loosen restrictions on marijuana in other regards has raised hopes
that it will take similar action that will help scientists. The
Justice Department said last year that it would not challenge state
laws legalizing marijuana, and in February, the Treasury announced new
guidelines meant to make it easier for cannabis businesses to open
bank accounts in states where the drug is legal.

Kevin Sabet, a former White House senior adviser for drug policy who
has been dubbed the No. 1 legalization enemy by Rolling Stone
magazine, said he supports efforts to break down barriers for
researchers. But he proposed that this could be done more efficiently
without rescheduling the drug - which remains highly controversial and
would have implications for the criminal justice system.

Sabet signed a letter sent this month to senior administration
officials by a coalition of people working in drug prevention and
related causes. The letter suggested that the DEA could instruct field
offices to process applications without delay after FDA approval and
could relax storage requirements for the components of marijuana used
in the context of an investigational new drug.

'The whole process is wrong'

In the brave new world of medical marijuana, family doctors,
psychiatrists and other community practitioners are the gatekeepers
and must determine whether a patient truly needs the drug. But in many
cases, doctors are prescribing the drug for their patients against the
recommendations of medical societies and with only limited research to
back up what they are doing.

"The whole process is wrong," said Andrew Weil, the American doctor
and author who conducted the first double-blind clinical trials of
marijuana in 1968.

"There is a great deal of evidence both clinical and anecdotal of its
therapeutic effects, but the research has been set way back by
government polices," Weil added.

"We are at the point where we are really just learning about this, and
for doctors that means a lot of experimentation," said Bonnie
Goldstein, a pediatrician who is medical director of the Ghost Group,
which manages WeedMaps.com, a searchable directory of doctors and
dispensaries.

In many states, for instance, marijuana is approved for pain and
prescribed for those with arthritis. But a study published in the
journal of the American College of Rheumatology this month found that
the effectiveness and safety of marijuana to treat conditions such as
arthritis are not supported by medical evidence.

Another condition for which medical marijuana is widely prescribed is
PTSD. Yet the American Psychiatric Association discourages doctors
from using it to treat psychiatric disorders. In a statement in
November, the APA said, "There is no current scientific evidence that
marijuana is in any way beneficial for the treatment of any
psychiatric disorder."

Sisley said she has been working with marijuana for several years to
treat soldiers returning from Afghanistan and Iraq who have
flashbacks, insomnia and anxiety, but she has had questions about
dosages that haven't been answered. Is one gram a day optimal? Or two?
Is it better to smoke the marijuana or use a vaporizer, which heats
ground marijuana leaves to produce a gas?

Sisley - who is working on the PTSD study with Rick Doblin, a
psychologist and executive director of the Multidisciplinary
Association for Psychedelic Studies - says she thinks the next big
political fight over marijuana may come from studies such as hers. If
research shows that marijuana is an effective medical treatment, it
could force the federal government's hand on reclassifying it.
- ---
MAP posted-by: Matt