We Need Proof on Marijuana #drugpolicy #cannabis

The New York Times
Wednesday, February 12, 2014

We Need Proof on Marijuana

By ORRIN DEVINSKY and DANIEL FRIEDMAN

MANY people have heard the story of Charlotte Figi, a young girl from
Colorado with severe epilepsy. After her parents began giving her a
marijuana strain rich in cannabidiol (CBD), the major nonpsychoactive
ingredient in marijuana, Charlotte reportedly went from having hundreds of
seizures per week to only two or three per month. Previously, her illness,
Dravet Syndrome, was a daily torture despite multiple high doses of powerful
anti-seizure drugs.

As news of Charlotte's story moved from the Internet to a CNN story by Dr.
Sanjay Gupta to Facebook pages, some families of children with similar
disorders moved to Colorado, which recently legalized marijuana, to reap
what they believe are the benefits of the drug.

Dozens of other anecdotes of miraculous responses to marijuana treatments in
children with severe epilepsy are rife on Facebook and other social media,
and these reports have aroused outsize hopes and urgent demands. Based on
such reports, patients and parents are finding official and backdoor ways to
give marijuana to their children.

But scientific studies have yet to bear out the hopes of these desperate
families. The truth is we lack evidence not only for the efficacy of
marijuana, but also for its safety. This concern is especially relevant in
children, for whom there is good evidence that marijuana use can increase
the risk of serious psychiatric disorders and long-term cognitive problems.

The recent wave of state legislatures considering and often approving
medical marijuana raises significant concerns. By allowing marijuana therapy
for patients with diseases such as difficult-to-control epilepsy, are state
legislatures endorsing the medical benefits and safety of a broad range of
marijuana species and strains before they have been carefully tested and
vetted? Marijuana contains around 80 cannabinoids (THC is the major
psychoactive cannabinoid, largely responsible for the high) and more than
400 other compounds. The chemical composition of two genetically identical
plants can vary based on growing conditions, soil content, parasites and
many other factors.

While the language of the legislation may be cautious, there is an implied
endorsement of medical benefit for marijuana when a legislature passes a
bill and a governor signs it into law, and the tremendous gaps in our
knowledge are not effectively conveyed to the public.

Where is the data showing that marijuana is effective for epilepsy?
Although parents may report improvements in their children, it is important
to remember that the placebo response is powerful, and the placebo response
is greater in pediatric than adult studies.

Before more children are exposed to potential risks, before more desperate
families uproot themselves and spend their life savings on unproven miracle
marijuana cures, we need objective data from randomized placebo-controlled
trials.
Recent Comments
Brian
9 hours ago

Why do we need "proof" on marijuana when we don't have it on some of the
most widely used drugs in America. Check out the peer reviewed...
Marc Wagner
9 hours ago

Fine approve it for consumption but not for SMOKING. Does anyone think it is
the nicotine that kills smokers? No, it is the combustion...
Jane
9 hours ago

Years ago, at that bastion of conservativism UC Berkeley, we got a lecture
in a toxicology class by a clinical researcher who was very...

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Based on studies showing that CBD can prevent seizures in animals and safety
data from patients treated with a drug containing CBD and THC in Europe for
multiple sclerosis spasms, we and other academic epilepsy centers are
planning a controlled trial with pure CBD. As an initial step, we have
approval from the Food and Drug Administration, the Drug Enforcement
Administration and the Bureau of Narcotic Enforcement to treat children with
CBD derived from marijuana plants in order to understand its safety and
tolerability and potential drug interactions.
This information will help us plan the placebo-controlled trials that we
hope will begin in 2014 and will be completed within two years. There is no
reason such studies cannot be done with other products derived from
marijuana, such as the oil with high CBD and low THC sold in Colorado that
was used by Charlotte Figi.

Paradoxically, however, as state governments increasingly make "medical"
marijuana available to parents to give to their children, the federal
government continues to label the nonpsychoactive CBD - as well as THC - as
Schedule 1 drugs. Such drugs are said to have "no currently accepted medical
use in the United States, a lack of accepted safety for use under medical
supervision, and a high potential for abuse." This designation hamstrings
doctors from performing controlled studies. While it is possible to study
Schedule 1 drugs in a controlled laboratory setting, it is extremely
difficult to study these substances in patients. For our study, we keep the
CBD in a 1,200-pound safe in a locked room, in a building with an alarm
system.

To foster research, we need to change compounds derived from marijuana from
Schedule 1 to a less restrictive category. It is troubling that while few
barriers exist for parents to give their children marijuana in Colorado,
there are significant federal roadblocks preventing doctors from studying it
in a rigorous scientific manner.

When patients have not been able to get successful medical treatment, and
they live in a state where the law allows medical marijuana for children -
we are not suggesting they smoke the drug - compassionate use is reasonable.

But for the long-term health of Charlotte and other patients like her, we
urgently need valid data.

----
Orrin Devinsky and Daniel Friedman are physicians at the NYU Comprehensive
Epilepsy Center.

A version of this op-ed appears in print on February 13, 2014, on page
A27 of the New York edition with the headline: We Need Proof on Marijuana.
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