vol1 - Page 249
Page 249
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a minimum of fifty additional research subjects were involved in
these confirmatory evaluations_ Other physicians, commenting
through respected medical journals, repol_c observing IOP reduc _
tions in more than 350 additional patients. _/ Dr. Merrittf in
additions reports acute and chronic evaluations of fifty
glaucomatose patients and approximately 8-10 glaucomatose
patients on a chronic basis_ _-_I/
Put simply, the number of research subjects involved in
timololSs NDA approval as an intraocular antihypertensive is
siqnificantly smaller than the number of research subjects
normo-tensive patients and glaucomatose patients evaluated for
!OP-lowering response to marijuana° The maximum number of human
subjects in the timolol studies -- all Phases o_ is around 400°
The minimum number of human subjects involved in marijuana-based
lOP lowering studies -- omitting human subjects involved in other
marijuana IND approved studies, and excluding the 250 additional
patients the New Jersey Protocol identifies as involved the
Hepler/UCLA Studys but not attributed elsewhere _- is
approximately 650 patients.
Undaunted, the government claims only lOP was evaluated
..... during the marijuana experiments_ When Ms. Shirley asked if
there are any studies to show marijuanans effect on visual fields
b
Green responds:
550/ ACT Official State Reports, Vol° !I_ Exhibit l0 at 19
(quoting D. Shapiro_ mThe Ocular Manifestations of the
Cannabinoids Ophthalmologica, 168:366-69)o
551/ /__. e_ also Affidavit of Dr. John Merritt_ _ 53.
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