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 For the Agency to argue almost ten years later that
 these programs are without value in determining marijuanats
 Waccepted medical use in treatment W for emesis because they were
 not implemented as randomized_ double-blind research studies is
 nonsensical. These programs were implemented as a result of a
 recognition and acceptance by the state legislature_ of marijuana
 as an antiemetic and unquestionably confirmed the accuracy of
 this legislative determinations
 As the Alliance demonstrated in its initial brief, all
 FDA-approved and DEA-sanctioned state studies were properly
 designed research programs. These well-controlled studies
 compared marijuana to other antiemetics such as oral THC or
 Torecan. _-_/ Under each state protocol, patients had to fail on
 at least one conventional antiemetic therapy to be eligible. In
 some state programs, such historical failure_even included THC
 capsules. This was unquestionably a valid control to assess the
 success or failure of the drug. _-_/ Phycological and biological
 tests were conducted on patients prior to entering the program
 and standard statistical procedures were utilized to evaluate
 ....... _2L/ ACT Brief at 49_91_ Robert J. Temple, Director of the
 Office of Drug Research and Review, Center for Drugs and
 Biologics, of FDA testified that in reviewing a proposed study
 under an IND_ FDA must be _sure the major studies are of adequate
 design so that their objectives can be met. If a study cannot
 meet its objectives_ it will not be permitted (i.e., it will be
 placed on clinical hold).# Affidavit of Robert Temple at 3o
 9__/ The historical control in this context includes the notion
 that the course of the medical problems emesis, is certainly
 predictable in the absence of an effective treatment° That is,
 after failing on one antiemetict patients will continue to suffe>__
 from emesis during and after each chemotherapy treatment, absent
 the utilization of an effective antiemetic -_ marijuana.
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