vol1 - Page 251
Page 251
Previous ,
Next ,
Original Image
Return to Index
Finallyt there is no evidence in the record, other than
Green's assertions to suggest timolol was approved for any india
cation other than the traditional indication: as an intraocular
antihypertensiVeo There is no evidence in the record to suggest
Merke, Sharp & Dome, the manufacturer of Timoptic, has ever
claimed use of Timoptic results in a retention of visual
field. _/ And the research on visual field retention which has
emerged since Timoptic's approval is e_remely contradictoryo _5-/
The AAO, in its #timely _ repc_rt_ _/ states na long
term clinical study, designedto test the safety and efficacy of
marijuana in the prevention of progressive optic nerve damage and
....... i
consequent visual field loss_ appears appropriateo w_5X/ There is
not indication in the record the AAO made similar demands prior
to Timolol's NDA approval.
.... >
When, during cross-examination by Mro Zeese, Keith
Green was asked why, nearly twenty years after Heplerts initial
report of lOP reduction, such a study had not been undertaken,
Dr. Green offered this revealing response:
___._/ ACT Rebuttal Exhibits_ B4® #Timoptic . . o has been shown
to be effective in lowering intraocular pressure .... n
........... 55_/ Cross_examination of Dr. John Merritt, Tr. I0-187. See
_19__ Affidavit of Dr. George Spaeth at p_ 7. Spaeth, in his
direct testimony, reports on a single patient study which sug _
gests timolol actually caused an erosion of visual function.
___._/ The Academy withheld its report which was concocted in
..... i_ 1984-85 until June 21, 1987. There is _o evidence to sugqest
that prior to release and in the two years between the com-
mitteeSs meeting and the Report's publication that the issue was
discussed beyond the limited, confines of the AAO Ad Hoc
Committee on Marijuana Leqislation.
55// Affidavit of Robert Randall_ Exhibit 15B, Affidavit of Dr_
Robert Helper, Exhibit 2_ p_ 4.
o
- -
Previous ,
Next ,
Return to Index