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 determine efficacy_ 15-_/ Finally, it is the only standard
 accepted as clinically valid by all ophthalmic witnesses in this
 proceeding.
 All ophthalmic witnesses, including government
 witnesses Greene _/ Hepler and Spaeth_ accept that the only
 _clinically effective", I_/ medically _validated #I_-_/ therapeut__
 indication for glaucoma therapy is _red_ction of intraocular
 pressure, x
 Rather than engage this issue_.DEA abandons the
 mtraditional, hiS-q/ indication for glaucoma _e_ reduction of
 IOP) to advance a Unew_ DEA fabricated therapeutic indication foz
 _accepted u glaucoma therapies_
 ...... /_.6/ Rebuttal Affidavit of Dr. John Merritt, _ 54.
 This standards the ability [of a drug] to
 reduce intraocular pressures_ has been
 recognized for decades as the ONLY reliable
 method for determining the utility of
 glaucoma control drugs_
 i___/ Cross-examination of Keith Green, Ph.D.s Tro 9-126. At
 Tr_ 9-!85 Green states, #One is trying to reduce the intraocular
 pressures to the lowest level that is possible in that
 patient
 o o o o
 15_8/ Affidavit of Dr. Robert S. Hepler, Exhibit 2 at 2.
 /__/ Affidavit of Dr_ George Spaeth at 7.
 /__q/ The word Htraditionaln means mhanded down by or conformin_i
 to tradition, n The word Xtraditionn has several meanings and is
 most appropriately defined as: "3. a long-standing custom or
 practice that has the effect of an unwritten law; specifoF any
 of the usages of a school or art or literature handed down
 through the generations and generally observed. _ Webster_s New
 World Dictionary of the American Languages 2d College Editions
 David B° Gurnlnik (ed) Simon & Schusters New York, 1980, at 1507
 56 -




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