Excerpts from the DEA letter released on Friday…..

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This is all a bunch of rehtorical nonsense. I bet Xanax didn’t have to jump through this many hoops….or vicodin….or morhine…….or ambient…..or any of the other ones that could actually kill you. -UA

Read the letter in its entirety…..http://americansforsafeaccess.org/downloads/CRC_Petition_DEA_Answer.pdf  these are just some of their phony claims….see the rest for yourself
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.

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 (http://

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.

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