vol1 - Page 362
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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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