vol1 - Page 366
Page 366
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This DEA _issue # is easily resolved by referencing
timolol_s PDR listed indication. If th_ DEA_s #new # theory of
...... utility was the accepted standard the PDR indication for timolol
(and other glaucoma therapies) would read mretention of visual
function, ul_q/ Significantly, no such indication is recognized
.... in the PDR° The only _indioation m for timolol noted in the PDR
is _reduction of intraocular pressure_ _3_/
Nor has the Utraditional_ standard (reduction of IOP)
been eclipseds as DEA alleges_ by the Agency's newly minted
standard_ Xn its _Statement on Marijuana, # approved less than a
year ago, the American Academy of Ophthalmology emphatically
states: #To date the only clinically effective method of . o o
[preventing damage to the optic disc_ is by lowering lOP. "!/I/
The Alliance submits that the onlyproper indication
for glaucoma therapy is the ntraditional,X long-accepted and
generally recognized indication Wreduction of intraocular
pressurep _ and that marijuana_ on the basis of all testimony_
controlled studies and other evidence introduced in these
proceedings, is generally accepted by the medical community as a_
effective intraocular antihypertensive agent.
16_/ While DEA's argument is directed at a nnew# standardt the
Agency does not actually specify what its proposed indication
would bee
17q/ ACT Rebuttal Exhibit B_4. #Timoptic . _ . has been shown
to be effective in lowering intraocular pressure .... n
a_ ACT Brief at 176_178.
171/ Affidavit of Dr_ Robert Hepler, Exhibit 2, nThe Use of
Marijuana in the Treatment of Glaucomas H American Academy of
Ophthalmology Statement as approved by the Board of Directors,
July 21_ 1987, at Io
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