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_P68 F_eml Re_ist_ / VoL 54, NOo _40 / Friday+ December _. 10_ / Notices
those with mul_pie sclereet˘ epilepsy, of nonoblJnd 0+udiee are queetionab_e and opens the door to replication of the
poor appetite, addiction to drugs end etncs they todd be at_buteble, in _ar_e s_diee. Unpublished stu_ee are
alcohol, palm and asthma. The evidence p_L_ tO psychological Peactiose of _therently euspecL
presented by the pro®marijuana parties eub]ecti rather theu any real e_ec_s While research studies with the
|nc|udes outdated and limited scientific from the experimental drug° The next limRetions mentioned above may
_tudlee_ chronicles of Lndividu_e. their factor which must be mir_mL_ed or provide useful and preliminary data
families and friends who have used etLm_ated for a reseeL_ study to be which will be valuable in desi_J_
_erilua_a; op|_one from over a dozen v_id _ the expectation of the f_,cth_r studJess research studies with
psyc_atr_sts and physicians_ co_˘t _searcher_ This is especially _'ue whets substantial lLcdta_ons are not suf_/cient
opinions lnvolvLng medic_ necessity as the effect busy.8 measured le sub_ec_ve to support a detern_LRat_on that a drug
a defense to cnndnal cheJ_e_ for illegal and not ob]ectiveo For example, if the has an accepted medical use° Both the
posse,each of mar_iuana; state statutes resea_cJher is evaluet/n8 if the patient i_ published and unpublished research
which made msH_usna available for _useatecL that is very sub|ect_Veo H the studies submitted by the pro-ma_iuana
rese_ch; newspaper articles; and the researcher knows which patient a_'e part_ee in this proceedLng to support
opt.mona of laypm_ons, L_cludi_ recetvLn_ the experimental _L.'_ his ma_juema'_ medical see suffer from
lawye_ end associations of lawyer+ perception of the _e_Jt_ todd be many deficiencies, They are0 in as*ante+
The A_L_i_is_retor does not fiud euch eigrm_c_tty MterecL preliminary e_ee_ None of the_
eclden_ convinc/n8 in lisht of the lack Other facto_ to be co_ide_ed wh_ _tu_ee has risen to the level of
of _elieble, credibM, and relevant evaluating the validity of _seareh demoa_trat/_8 that marijuana ha+ a_
ecien_L_c etudJee documenth_g Ln_ude the number of subjects _ the accepted medical use for treatment of
mefl_uana's medical utility: the opinions study, how the subjects are selected for any medical condition The three
of highly respected, credentieled experts the study, the length of the study, o_ how medical conditions for which the
that marijuana doe_ not have an many tL_es the experimental drag is majority of evidence in the record was
accepted medical use: and statements admh_stered, an6 the measurement of presented are: (1) Nausea and vomfling
f_m the American Medical Aaso_stto_ results in quantifiable, obiective terms, associated with chemotherepy_ (_)
the American Cancer _ociety_ the The fewer the _ub_ecte Lu _ rese_h glaucoma, and (3) spasti_W associated
American Academy of OphthalmoloSy, study, the less valid the results, if the with amputation or multiple sclerosis.
the National Multiple Sclerosis SeeSaW+ sample of sub_e_t_ Is not stat_stlcalJy Evidence presented in each ares will be
and the Federal Food and Drug elgnfficanL the chances of the ease discussed separately.
Ac_ninistrefion that mal_u_na has e. ot reSetS beLP_ duplicated in other Naumm emd Vo_ting
been demom_atad as audible for _e individuals is reducekL Sub|ecru for a
as e medicine. Each of these e_eae will rematch _tudy should b, randomly Five stsdlee were presented by the
be diectmeed separately, selected and rep_senteLivs of the pro_menqjuena parties to suppor_ the
The record cont_ many mseen_ch pop,afteR that is targeted to use the medical use of marijuana as an
stu_ee which have bees published in cl_u_, Te_th_ of mazljuen_ in cence_ antlemetlc_ The first study by SeLle_ et
scientific journals end many pa_ente for relief of nausea and aim A_tiemetie _ect of De/t_-9_
unpublished _m_ee conducted by . vo_Lu_ _bould not be limited to _o_e Tetz_hydz_oc_ab/na] in Pat/ent_
individual sties. In order to evaluate who have previously used mar_|uana Receiving Canoes _emothempy, _3
the validity of any research study many _creationa|ly and request its use in _e New F,_and Journal of Me_c_ne+ 79_
fa_ore must be considered_ Certain s_dy. The length of a study is 7_'(!9_). utilized synthe_c
scientific practices have bees generaJJy partJcul_|y significant when the drew is tetrshydrocannab_ol {THC] and sot th+
accepted by the scientific commur_ty to be used to t_ea_ a cchr_n_c c_ndit_on plant materiel marijuana. Although
which are designed to fnc_see the such as glaucoma oe spaettci_d. _d_Lee deita-g:l_-tC is an ecttve ingredient Lu
velidi W of experimental e_dieeo $_dies based upon avute or one_tLms the marijuana plant materiel, marijuana
or reeeeLrch projects which do not follow admL_tst_tion of the _ must _ contains over 400 other chemicals. At
these accepted s_entific practices have viewed with caution when the goal is least 81 of the_e chemicals are
very limitetL if eLny_ credibility. A review treatment of a chronic conditiolL The carmabinoids. All these chemicals could
of such studies must first examMe the effectiveness of the drug for IOngotlme have _ome effect on the human body.
de_ to which reseeLrche_ control or adminie_ation _nd tb_ existence of +ida Since THC t_ only one of many active
hold constant, all the variables which efface resulting _rom echronic u,e will _grediente in marijuana, THC studies
could affect the requite, except the not be _vea]ed in acute studies+ are of very limited valse in evaluatLn_
variable being studied. For exempts, if _ addition to factors minted to the the therapeutic utility of marijuana. The
you wish to evMuate the MTecflveneu of desi_ and execution of • _sea_.,h _'oute of echnL_istratiom em_okin_ ve_us
marijuana on a group of glaucoma study0 there are two other factors which oral _ecflon_ le a sisniflc_t difference
patient, you must control _y oth_ must be _viewad in evaluaL_on of a between use of marijuana and THCo
medication which the patient is tsklzig, research _tUdyo Rese_xch reeul_ am Therefore, the results of the eel!an studs,
Otherwise, fl Je Impdssible to conclude always _nsidered tentative or are of little or no benefit in evaluating
that the resets am et_butable to the preliminary u_ they have been the medlc_,_ utility of merljuena for
meuPijmmao replicated or confirmed by another _eatment of nausea end vomiting
The second factor, or aepe_ of the _ese_,,her. The research e_dy must be associated with chemotherapy.
design of a reeeareh project which must _epo_ed in sufficient detail to parer 'The second study compeLred a
.... _
b_ eveduated, ie the placebo effect. _e others to repeat IL Finally, publie_el_on combination of pure THC end marijuems
: is the tendency of _search subjects to of a study in a ectenthqc _ommaL to placebo cigarettes. This study by
e_ and respond in a manner they espeoialiy a |ournel which subjects an Chang, st el.+ Delta
believe i_ expected of them_ To article to review prior to publfcatio_, Tetmhydtoconnob/no] _e on .,edit/emetic
eliminate this factor, reseew,k subject= adds vMidity to a study. Journal /n CanceJ" Peb_nt$ Bece/_/ng H/ghoDOSe
usually "blinded," or not tvdorme_:L pubL_mition sub|eels a study to review Metho_exote, _ A.unels of Internal
of whet _ they ere _c_d_rL_. Ree_t_ _ _cz_tiny by the _ien_c oommur_y Medicine, _ (1_), was
....
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