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.
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.
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