Pubdate: Fri, 12 Aug 2016
Source: New York Times (NY)
Copyright: 2016 The New York Times Company
Author: Catherine Saint Louis


The Drug Enforcement Administration's decision on Thursday to not 
remove marijuana from the list of the nation's most dangerous drugs 
outraged scientists, public officials and advocates who have argued 
that the federal government should recognize that marijuana is 
medically useful.

Reclassifying marijuana from a Schedule 1 drug to a Schedule 2 drug 
would have made it easier to get federal approval for studies of its 
uses and paved the way for doctors to eventually write prescriptions 
for marijuana-derived products that could be filled at pharmacies, 
like other Schedule 2 drugs such as Adderall, which is used to treat 
attention deficit hyperactivity disorder.

Eight Democratic legislators had urged the D.E.A. to reclassify 
marijuana to a Schedule 2 drug. Senator Elizabeth Warren of 
Massachusetts voiced her disappointment with the decision on Twitter. 
Senator Kirsten Gillibrand of New York said in a statement, "It 
shouldn't take an act of Congress for the D.E.A. to get past 
antiquated ideology and make this change."

Yet in a separate policy proposal also issued on Thursday, the agency 
handed researchers and advocates a victory in removing a significant 
roadblock to medical studies of marijuana. The D.E.A. said it will 
allow universities and even private companies to apply to grow 
marijuana for scientific research. For many years, the University of 
Mississippi has had a monopoly on that role as the sole 
D.E.A.-approved provider of marijuana, and researchers have long 
complained that the supply of the drug was grossly inadequate, 
stymying efforts to establish whether marijuana is an effective 
treatment for many diseases.

Chuck Rosenberg, the acting head of the D.E.A., wrote in the decision 
that marijuana would remain a Schedule 1 drug because "it has no 
currently accepted medical use in treatment in the United States, a 
lack of accepted safety for use under medical supervision, and a high 
potential for abuse." He said these criteria are set out in the 
Controlled Substances Act, which mandates scheduling decisions based 
on scientific data.

"Research is the bedrock of science," he wrote, "and we will - as we 
have for many years - support and promote legitimate research 
regarding marijuana and its constituent parts."

The District of Columbia and 25 states now allow the use of marijuana 
for a wide variety of medical conditions. The scientific evidence of 
its effectiveness is thin to nonexistent for many illnesses, 
including rheumatoid arthritis, Tourette's syndrome and lupus. 
Reputable studies have shown it can relieve nausea, improve appetite 
and ease painful spasms.

But there is no drug derived from marijuana that has yet been 
approved by the Food and Drug Administration.

Epilepsy and Medical Marijuana

Catherine Saint Louis, a Times reporter, talked with Michelle Mensel 
and her daughter Becca who has a severe form of epilepsy called 
Dravet Syndrome.

Under the previous policy, marijuana supplied by the University of 
Mississippi could not be used legally to develop marijuana-derived 
drugs for F.D.A. approval and for eventual commercial sale. The new 
policy changes that. Marijuana grown by approved institutions will 
qualify for use in clinical trials seeking the approval of federal 
regulators, and can be marketed.

Some experts and advocates argued that ending the University of 
Mississippi's de facto monopoly on growing research-grade marijuana 
was more important to spurring research than reclassifying the drug. 
Paul Armentano, the deputy director of the National Organization for 
the Reform of Marijuana Laws, said that "removing this arbitrary 
hurdle to research could have more significant ramifications than 
simply rescheduling from 1 to 2."

Rick Doblin, executive director of the Multidisciplinary Association 
for Psychedelic Studies, which is funding a trial of marijuana as a 
treatment for post-traumatic stress disorder in veterans, agreed. 
"That was the key obstruction," he said.

Michael Felberbaum, an F.D.A. spokesman, said on Thursday, "We 
continue to encourage work to assess whether there are appropriate 
and effective therapeutic uses of marijuana and its components and 
believe the drug approval process using scientifically valid and 
well-controlled clinical trials is the most appropriate way for this to occur."

Currently Epidiolex, a marijuana-derived liquid, is going through 
clinical trials to determine its effectiveness and safety for the 
treatment of seizures in children. It uses cannabidiol, an ingredient 
in marijuana also known as CBD, that does not induce a high. Mr. 
Rosenberg said in his letter that if CBD proved safe and effective 
for the treatment of childhood epilepsy, "that would be a wonderful 
and welcome development."

Some drug policy experts nonetheless said the refusal to reschedule 
marijuana would hamper research. "They are placing researchers in a 
Catch 22, by saying 'We are not lifting this research barrier because 
there's not enough evidence.' But then people say, 'We can't do 
research because of this barrier,'" said Michael Collins, the deputy 
director of national affairs at the Drug Policy Alliance, which 
supports the legalization of marijuana.

Others were thrilled the D.E.A. did not budge. "At present, rigorous 
evidence does not support the use of marijuana for medical 
conditions, especially as short- and long-term consequences are not 
adequately documented in patients," said Bertha K. Madras, a 
professor of psychobiology at Harvard Medical School. "Increasingly, 
scientific evidence shows marijuana to be harmful, and especially for 
young people." She called the agency's decision "a victory for 
science that, to me, is very comforting."

But the key question now is funding, Dr. Doblin said. Will drug 
companies spend large sums to run clinical trials to develop 
marijuana-derived medicines?

"One competitive advantage, if you make it through the F.D.A., is 
insurance companies will cover it," Dr. Doblin said. But he added 
that the potential disincentive was obvious: Marijuana is widely 
available on the street and many states have approved the sale of 
marijuana for medical purposes.
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MAP posted-by: Jay Bergstrom