Pubdate: Sun, 10 Aug 2014
Source: New York Times (NY)
Copyright: 2014 The New York Times Company
Website: http://www.nytimes.com/
Details: http://www.mapinc.org/media/298
Author: Serge F. Kovaleski

MEDICAL MARIJUANA RESEARCH HITS WALL OF U.S. LAW

Nearly four years ago, Dr. Sue Sisley, a psychiatrist at the
University of Arizona, sought federal approval to study marijuana's
effectiveness in treating military veterans with post-traumatic stress
disorder. She had no idea how difficult it would be.

The proposal, which has the support of veterans groups, was hung up at
several regulatory stages, requiring the research's private sponsor to
resubmit multiple times. After the proposed study received final
approval in March from federal health officials, the lone federal
supplier of research marijuana said it did not have the strains the
study needed and would have to grow more - potentially delaying the
project until at least early next year.

Then, in June, the university fired Dr. Sisley, later citing funding
and reorganization issues. But Dr. Sisley is convinced the real reason
was her outspoken support for marijuana research.

"They could never get comfortable with the idea of this controversial,
high-profile research happening on campus," she said.

Dr. Sisley's case is an extreme example of the obstacles and
frustrations scientists face in trying to study the medical uses of
marijuana. Dating back to 1999, the Department of Health and Human
Services has indicated it does not see much potential for developing
marijuana in smoked form into an approved prescription drug. In
guidelines issued that year for research on medical marijuana, the
agency quoted from an accompanying report that stated, "If there is
any future for marijuana as a medicine, it lies in its isolated
components, the cannabinoids and their synthetic derivatives."

Scientists say this position has had a chilling effect on marijuana
research.

Though more than one million people are thought to use the drug to
treat ailments ranging from cancer to seizures to hepatitis C and
chronic pain, there are few rigorous studies showing whether the drug
is a fruitful treatment for those or any other conditions.

A major reason is this: The federal government categorizes marijuana
as a Schedule 1 drug, the most restrictive of five groups established
by the Controlled Substances Act of 1970. Drugs in this category -
including heroin, LSD, peyote and Ecstasy - are considered to have no
accepted medical use in the United States and a high potential for
abuse, and are subject to tight restrictions on scientific study.

In the case of marijuana, those restrictions are even greater than for
other controlled substances. (Marijuana remains illegal under federal
law, though nearly half the states and the District of Columbia allow
its medical use and two, Colorado and Washington, have legalized its
recreational use.)

To obtain the drug legally, researchers like Dr. Sisley must apply to
the Food and Drug Administration, the Drug Enforcement Administration
and the National Institute on Drug Abuse - which, citing a 1961 treaty
obligation, administers the only legal source of the drug for
federally sanctioned research, at the University of Mississippi. Dr.
Sisley's proposed study also had to undergo an additional layer of
review from the Public Health Service that is not required for other
controlled substances.

The process is so cumbersome that a growing number of elected state
officials, medical experts and members of Congress have started
calling for loosening the restrictions. In June, a letter signed by 30
House members, including four Republicans, called the extra scrutiny
of marijuana projects "unnecessary," saying that research "has often
been hampered by federal barriers."

"It defies logic in this day and age that marijuana is still in
Schedule 1 alongside heroin and LSD when there is so much testimony to
what relief medical marijuana can bring," Gov. Lincoln Chafee of Rhode
Island said in an interview. In late 2011, he and the governor of
Washington at the time, Christine O. Gregoire, filed a petition asking
the federal government to place the drug in a lower category. The
petition is still pending with the D.E.A.

Yet despite the mounting push, there is little evidence that either
Congress or the Obama administration is interested in changing
marijuana's status. And in public statements, D.E.A. officials have
made their displeasure known about states' legalizing medical and
recreational marijuana.

The agency's position seems at odds with that of President Obama,
whose Justice Department has allowed states to legalize either medical
or recreational marijuana as long as they follow certain federal
priorities, such as not allowing sales to juveniles. Mr. Obama has
also said that he believes marijuana is no more dangerous than alcohol
and that he is bothered by the disproportionate number of minorities
incarcerated for possession of the drug.

Asked if there was an inconsistency between the president's stance and
that of the Drug Enforcement Administration, a White House spokesman,
Matt Lehrich, said: "The administration's policy continues to be that
while the prosecution of drug traffickers remains an important
priority, targeting individual marijuana users is not the best
allocation of federal law enforcement resources. The D.E.A. is
carrying out that policy."

There are signs, though, of a possible shift in attitude within the
federal government. In May, the D.E.A. issued new rules to increase
the government's production of marijuana for research this year to
650,000 grams from 21,000 grams.

And at the National Institute on Drug Abuse, for instance, records
show that at the beginning of this year there were 28 active grants
for research into the possible medical benefits of marijuana in six
disease categories. Most of the studies focus on the potential
therapeutic uses of individual cannabinoid chemicals from marijuana or
synthetic versions and not the plant itself. Furthermore, a dozen or
so of those studies are being conducted with animals and not humans.

Additionally, other National Institutes of Health entities have been
supporting marijuana research. As for independently funded marijuana
research, the federal government has cleared 16 projects since 1999,
13 of them at the University of California, San Diego.

Moving the drug to a less restrictive category could do more than
reduce some obstacles to research, proponents say. It would be a
significant step toward allowing doctors around the country to
prescribe the drug. Federal lawmakers say it could also permit medical
marijuana operations that are legal at the state level to take
business deductions on their federal taxes.

Dr. Sisley's predicament shows that even in states like Arizona, where
medical marijuana is legal, the matter remains politically volatile.
Last month, Arizona authorized the use of marijuana for patients
undergoing conventional treatments for post-traumatic stress disorder
under certain circumstances. Dr. Sisley's study is supposed to use
five different strains of marijuana that would be smoked or vaporized
by 70 veterans. The goal is to develop a marijuana drug, in plant form
that would be smoked and vaporized, approved by the Food and Drug
Administration.

Her firing seemed to stem from a fight over money. In March, the
Arizona House passed a Republican-sponsored bill designed to provide
her project with some funding from fees collected in the state's
medical marijuana program. But the measure died when State Senator
Kimberly Yee, a Republican who is the chairwoman of the Education
Committee, refused to put the legislation on the panel's agenda. Ms.
Yee said at the time that she preferred the funds be used for antidrug
education.

Angry about her opposition to the bill, a group of veterans began a
recall effort against Ms. Yee. Some of those veterans had been treated
by Dr. Sisley in the past, and Senate leaders concluded that Dr.
Sisley herself was involved in the campaign.

The State Senate president, Andrew Biggs, called the university's
chief lobbyist, Tim Bee, to complain that Dr. Sisley seemed to be
lobbying too aggressively and inappropriately.

"Tim said he would call me back after he found out more," Mr. Biggs
said in an interview. "And then he did and told me, 'This will not be
a problem going forward.' "

In April, a university vice president, who said he was calling on
behalf of the president, Ann Weaver Hart, told Dr. Sisley that Mr.
Biggs thought she should resign, Dr. Sisley recounted. In June, she
received a letter from the university saying her annual employment
contract would not be renewed as of Sept. 26.

Dr. Sisley denied participating in the recall effort. She acknowledged
talking to senators and their aides about funding, but as a member of
the Arizona Medical Association.

"The university could not take the political heat from the
hyperconservative legislators and fired me and deserted all these
veterans who have been fighting alongside me for years," she said.

A university spokesman, Chris W. Sigurdson, said that while university
policy prevented him from discussing specifics about Dr. Sisley's
case, the school had not been pressured to fire her. (Mr. Biggs also
denied trying to get her fired.) He added that the university had
proposed that another faculty member take over the project as lead
investigator.

Late last month, the university notified Dr. Sisley that it had denied
her appeal for reinstatement. Rick Doblin, founder and executive
director of the Multidisciplinary Association for Psychedelic Studies,
which is sponsoring Dr. Sisley's research, said he would now try to
persuade the Arizona Board of Regents to allow the study to continue
at another state institute with Dr. Sisley as the lead
investigator.

Mr. Doblin said he was committed to staying with her as the lead
investigator and would help her look for an alternate research
location. A switch to a new study location would require further
regulatory review for the proposed research, which still needs another
approval from the D.E.A., Mr. Doblin said.
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MAP posted-by: Matt