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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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