vol1 - Page 314
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and well controlled investigations prior to the commercial
marketing of a drug. A variety of controls including historical_
active, and others are recognized by FDA as valid means to
determine Kefficacy. Ul_-/ Thus, not even FDA demands solely
double-blind studies to determine mefficacym for marketing.
_As discussed more fully below, not only are there a
nnmherofdouble-blind, randomized studies demonstrating
marijuana's medical utility, but all the studies discussed by
the Alliance in its initial brief were PDA authorized and DEA
sanctioned. Thus, they constitute adequate and well controlled
investigations producing useful and statistically significant
results. I-_/
Xn sum, DEA has not merely disregarded the GrinsDoon
decision and defined _acceptance x based upon nefficacy, N the
Agency has contemptuously ignored the First Circuit and inflated
the efficacy requirement by mandating that marijuana be the
#perfect drug, _ and that proof of this perfection may only be
derived through the use of double-blind studies. This
I_/ Cross-examination of Dr. Denis Petro, Tr. 6-139.
1_4/ As discussed infra Section V(A) the states sponsoring the_e
programs had already reached the conclusion that marijuana had
an accepted medical use in treatment. FDA, however, demanded
that these treatment programs take the form of research studies
employing scientific controls. The results of these studies
demonstrated conclusively that marijuana indeed has medical
utility just as the states had initially determined. In this
proceeding, DEA_ on a larger scale, is simply repeating this
confrontation. Now 34 states accept marijuanaSs medical utility
and yet the government demands a retrograde series of additional
double-blind studies. In the case of marijuana, the demand by
DEA that the drug's medical utility be demonstrated yet again i_i_
plainly loathsome and disingenuous°
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