vol1 - Page 248
Page 248
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How does this compare with research populations
involved in marijuana/IOP studies? Dro Hepler evaluated a
minimum of 225_250 subjects. 547/ Few of these evaluations
involved acute single response studies° Instead, most of his
evaluations lasted 34 or 90 days, and, in nearly all instanoes_
the-research was conducted under extremely strict controls --
including hospitalization of the research subject for around-
the-clock observation randomization of subjects, use of double s
masked placebo controls. _-_/ The Hepler study also included a
minimum of 12 to 15 glaucomatose patients. 5_/ Other researchers
evaluated small numbers of subjects (Cooler & Gregg, Purnell &
..... ii _
Gregg, Perez-Reyes (____;__) etc). Conservative estimates suggest
5___/ Attempts to determine the precise number of research
subjects and glaucoma patients involved in Dr. Hepler°s six ?ear
UCLA study are daunting® The New Jersey Department of Health es
1985 Glaucoma Protocol indicate approximately 425 people were
evaluated during the UCLA program. Sees ACT Official State
Reports, New Jersey Glaucoma Protocol Vol® Ii, Ex_hibit I0 at 22.
Hepler, in his 1978 Affidavit, notes that by early 1974 more
than 70 subjects had been evaluated and that his study was
#expanded w for larger populations, including persons with°
glaucoma. Still other sources indicate, that by mid-1976 at the
conclusion of Hepleres study approximately 225_250 people were
involved in the 34 and 90 day trials. Another 12_15
glauoomatose patients were evaluated for IOP response for
varying periods of time, from one day, acute response testsf to
..... • extended evaluations which, in at least one case, Robert
Randall, extended over 2 weeks of in-hospital evaluation. Since
the New Jersey Department of Health estimate is unattributed and
Hep!er notes that by 1974 over 70 patients had been evaluated and
his study was expanding and because data not in the record
strongly indicates a total population of between 225_275, the
Alliance will accept this fig_are as a reasonable approximation of
the UCLA/Marijuana Research Projects IOP study population.
5_8/ Affidavit of Keith Green, PhoD., Exhibits 2_ 3 & 7; see
also ACT Scientific Journal Articles_ Exhibits C2, C4 & C5.
..... / 549/ Affidavit of Robert Randali_ Exhibit 2B, Affidavit of
Robert Hepler at _ 19.
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