To establish accepted medical use, among other criteria, the effectiveness of a drug must be established in well-controlled scientific studies performed in a large number of patients. To date, such studies have not been performed for marijuana. Small clinical trial studies with limited patients and short duration such as those cited by the petitioner are not sufficient to establish medical utility. Larger studies of longer duration are needed to fully characterize the drug’s efficacy and safety profile. Anecdotal reports, patients’ self-reported effects, and isolated case reports are not adequate evidence to support an accepted medical use of marijuana (57 FR 10499, 1992). In addition to demonstrating efficacy, adequate safety studies must be performed to show that the drug is safe for treating the targeted disease. DHHS states that safety studies for acute or subchronic administration of marijuana have been carried out through a limited number of Phase 1 clinical investigations approved by the FDA, but there have been no NDA-quality studies that have scientifically assessed the efficacy and full safety profile of marijuana for any medical condition.
DEA further notes that a number of clinical
studies from CMCR have been discontinued.
Most of these discontinuations were due to
recruitment difficulties (https://
www.cmcr.ucsd.edu/geninfo/research.htm
(last retrieved 07/07/2010) (listing 6
discontinued studies, 5 of which were
discontinued because of recruitment issues)).
The petitioner states that the
pharmacological effects are well established
for marijuana and D9
-THC, using the
argument that Marinol (containing synthetic
D9
-THC, known generically as dronabinol)
and Cesamet (containing nabilone, a
synthetic cannabinoid not found in
marijuana) are approved for several
therapeutic indications. The approvals of
Marinol and Cesamet were based on well-
controlled clinical studies that established
the efficacy and safety of these drugs as a
medicine. Smoked marijuana has not been
demonstrated to be safe and effective in
treating these medical conditions. Marijuana
is a drug substance composed of numerous
cannabinoids and other constituents; hence
the safety and efficacy of marijuana cannot be
evaluated solely on the effects of D9
-THC.
Adequate and well-controlled studies must
be performed with smoked marijuana to
establish efficacy and safety. DHHS states
that there is a lack of accepted safety for the
use of marijuana under medical supervision.
The petitioner has not submitted any new
data meeting the requisite scientific
standards to support the claim that marijuana
has an accepted medical use in the United
States. Hence, the new information provided
by the petitioner does not change the federal
government’s evaluation of marijuana’s
medical use in the United States.
Here’s the part that says we don’t know what we are experiencing……
DEA further explained in the same ruling
that,
Scientists call [stories by marijuana users
who claim to have been helped by the drug]
anecdotes. They do not accept them as
reliable proofs. The FDA’s regulations, for
example, provide that in deciding whether a
new drug is a safe and effective medicine,
‘‘isolated case reports will not be
considered.’’ 21 CFR 314.126(e). Why do
scientists consider stories from patients and
their doctors to be unreliable?
First, sick people are not objective
scientific observers, especially when it comes
to their own health. [. . .] Second, most of
the stories come from people who took
marijuana at the same time they took
prescription drugs for their symptoms. [. . .]
Third, any mind-altering drug that produces
euphoria can make a sick person think he
feels better. [. . .] Fourth, long-time abusers
of marijuana are not immune to illness.
[. . .] Thanks to scientific advances and to
the passage of the Federal Food, Drug and
Cosmetic Act (FDCA) in 1906, 21 U.S.C. 301
et seq., we now rely on rigorous scientific
proof to assure the safety and effectiveness of
new drugs. Mere stories are not considered
an acceptable way to judge whether
dangerous drugs should be used as
medicines.
Thus, patients’ anecdotal experiences with
marijuana are not adequate evidence when
evaluating whether marijuana has a currently
accepted medical use.