vol1 - Page 241

 i
 infra, all Government witnesses acknowledged that reductions in
 ocular tension is the only #validated #, mclinically effective x
 method of treatment.
 Mro Zeese questioned Keith Groen, Ph.D, about this
 relationships Green responds:
 IT]he evidence that exists from many_ many
 series of studies seems to suggest that if
 you reduce pressure, then _ . . those
 characteristic changes that normally would
 occur _;glaucoma] donet occur with the same
 .....: speed. _u_1
 Dr. North, a former FDA IND/NDA ophthalmic drugs review
 officer, was asked, on cross-examination by Ms. Mapes, to
 articulate the accepted standard of medical utility in the
 treatment of glaucoma.
 Mapes: What would you say would be necessary
 to establish that a drug has a currently
 accepted medical use [in] treatment [of
 ..... glaucoma]?
 North: That it does reduce the intraocular
 pressure to levels that are o
 _/beneficiai
 [in the] therapy of a patient.
 In the dialogue which follows, Dr. Nor_ explains:
 [D3rugs have specific indications for
 specific diseases .... [W]eSre talking
 about reduction of intraocular pressure [as
 the indication]. Does a drug indeed reduce
 intraocular pressure? Finer if it does then
 what are the side effects? [What is_ the
 benefitrisk ratio [and does it] warrant the
 use of that drug for those particular indi _
 cations [_ reduction of intraocular
 pressure_? _I
 .... 




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