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In the MDMA third final order DEA is actually making the decision  
that doctors have to make, rather than trying to ascertain the decision  
which doctors have made.  Consciously or not, the Agency is undertaking  
to tell doctors what they should or should not accept.  In so doing the  
Agency is acting beyond the authority granted in the Act. 
     It is entirely proper for the Administrator to consider the  
pharmacology of a drug and scientific test results in connection with  
determining abuse potential.  But abuse potential is not in issue in this  
marijuana proceeding. 
     There is another reason why DEA should not be guided by FDA criteria  
in ascertaining whether or not marijuana has an accepted medical use in  
treatment.  These criteria are applied by FDA pursuant to Section 505 of  
the Federal Food, Drug and Cosmetic Act (FDCA), as amended. [footnote 13]   
When the FDA is making an inquiry pursuant to that legislation it is  
looking at a synthetically formed new drug.  The marijuana plant is  
anything but a new drug.  Uncontroverted evidence in this record  
indicates that marijuana was being used therapeutically by mankind 2000  
years before the Birth of Christ. [footnote 14] 
     Uncontroverted evidence further establishes that in this country  
today "new drugs" are developed by pharmaceutical companies possessing  
resources sufficient to bear the enormous expense of testing a new drug,  
obtaining FDA approval of its efficacy and safety, and marketing it  
successfully.  No company undertakes the investment required unless it  
has a patent on the drug, so it can recoup its development costs and make  
a profit.  At oral argument Government counsel conceded that "the FDA  
system is constructed for pharmaceutical companies.  I won't 
____________________ 
13   21 U.S.C. Sec. 355. 
14   Alice M. O'Leary, direct, par. 9. 
                                  - 33 - 
deny that." [footnote 15] 
     Since the substance being considered in this case is a natural plant  
rather than a synthetic drug, it is unreasonable to make FDA-type  
criteria determinative of the issue in this case, particularly so when  
such criteria are irrelevant to the question posed by the act: does the  
substance have an accepted medical use in treatment? 
     Finally, the Agency in this proceeding relies in part on the FDA's 
recommendation that the Administrator retain marijuana in Schedule I.   
But, as in the MDMA case, that recommendation is based upon FDA's  
equating "accepted medical use" under the Act with being approved for  
marketing by FDA under the Food, Drug and Cosmetic Act, the  
interpretation condemned by the First Circuit in the MDMA case.  See  
Attachment A, p.24, to exhibit G-1 and exhibit G-2. 
     The overwhelming preponderance of the evidence in this record  
establishes that marijuana has a currently accepted medical use in  
treatment in the United States for nausea and vomiting resulting from  
chemotherapy treatments in some cancer patients.  To conclude otherwise,  
on this record, would be unreasonable, arbitrary and capricious. 
____________________ 
15   Tr. XV-37. 
                                  - 34 - 
                                   VI.
                    ACCEPTED MEDICAL USE IN TREATMENT
                               - GLAUCOMA
Findings of Fact
     The preponderance of the evidence establishes the following facts 
with respect to the accepted medical use of marijuana in the treatment of
glaucoma.
          1.  Glaucoma is a disease of the eye characterized by the 
excessive accumulation of fluid causing increased intraocular pressure, 
distorted vision and, ultimately, blindness.  In its early stages this 
pressure can sometimes be relieved by the administration of drugs.  When 
such medical treatment fails adequately to reduce the intraocular 
pressure (IOP), surgery is generally resorted to.  Although useful in 
many cases, there is a high incidence of failure with some types of 
surgery.  Further, serious complications can occur as a result of 
invasive surgery.  Newer, non-invasive procedures such as laser 
trabeculoplasty are thought by some to offer much greater efficacy with 
fewer complications.  Unless the IOP is relieved and brought to a 
satisfactory level by one means or another, the patient will go blind.
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