vol1 - Page 342
Page 342
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emesisW. _-_/ In additions contrary to _e assertions made by DEAn
an FDA official stated in 1980 that the _[New Mexico Program was]
a careful comparison between marijuana cigarettes and the THC
capsules#. _-_/
In fact, many patients in the New Mexico study were
randomized. _-_/ New Mexico officials_ however, eventually
discovered that some patients refused to take the capsules while
others refused to smoke. _L_/_ To eliminate this problem the New
Mexico protocol was amended -_ with FDA approval -= to allow
patients to select their form of therapyo ._-_-/ The National
Cancer Institute and the National Institute on Drug Abuse
reviewed the New Mexico protocol and made no objections to these
adjustments. _-_/ Significantly, a later analysis of the results
9_/ It is interesting to note that, despite these attacks on
the study and thus the validity of the data obtained there from_
the Agency relies on its findings when it favors its position°
DEA Brief at 33o
9_/ ACT Official State Reports, Vol. If, Exhibit I0 New Jersey
Cancer Protocol at 13 (quoting from hearings Before the Select
Committee on Narcotic Abuse & Controls Therapeutic Uses of
Marijuana and Schedule I Drugs, U.S. House of Representatives
96th Congress, 2d Sess., May 20, 1980_ at 77, opinion of Dr.
Richard Croutt Director of the Bureau of Drugs, Federal Food and
Drug Administration.)
__6/ Affidavit of Dro Daniel Dansak, at _ 39; Cross_examination
of Dr. Daniel Dansak, Tr. II_32 (nearly 70 patients were
randomized).
....... 9// Cross-examination of Dr. Daniel Dansak, Tr. ii-32.
98/ Affidavit of Dro Daniel Dansak, _ 39; Cross-examination of
Dr. Daniel Dansak, Tr. 11-96o
_/ Cross-examination of Dr. Daniel Dansak_ Tro 11-97 & Ii-98_
..... 36 -
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