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h e a c t o f p re sc rib in gin te re ste d p a rtie s: a n y d ru g in v o lv e sth e d ru g m a n u fa c tu re r;a t le a st th re eth e in d iv id u a l p re sc rib in g th e d ru g ; a n d th e p a tie n t. In a sim p listic w a y , a ll th re e p a rtic ip a n ts in th is p ro c e ss sh a re a c o m m o n in te re st in a m e lio ra tin g o r re so lv in g th e p ro b le m th a t c a u se d th e p a tie n t to se e k m e d ic a I a tte n tio n . O th e r in te re sts, n o t a ll o f w h ic h w ill b e c o m m o n to e a c h o f th e se th re e p a rtic ip a n ts, m a y b e p re se n t c o n sc io u sly o r u n c o n sc io u sly .T o o b ta in a lic e n c e fo r its c o m m e rc ia liz a tio n , e v e ry d ru g m u st sa tisfy a se rie s o f n o rm s th a t v a ry fro m c o u n try to c o u n try . T h e se n o rm s g e n e ra lly re q u ire d o c u m e n ta tio n o f th e m in im u m a n d a c c e p ta b le risk o f se rio u s o r fre q u e n t sid e e ffe c ts o f th e d ru g , a s w e ll a s re q u irin g it to b e e ffe c tiv e a n d e ffic a c io u s w ith in its p ro p o se d ta rg e t p o p u la tio n .
W ith th e c o n sta n t a d v a n c e o f te c h n o lo g y , a n d th e re c o g n itio n th a t re so u rc e s a llo tte d to h e a lth c a re a re fin ite a n d p ro p o rtio n a lly m o re a n d m o re sc a rc e ,. th e re h a s b e e n a re c e n t-te n d e n c y to re q u ire th a t a n e w d ru g b e a s, o r m o re , e ffic ie n t th a n th o se a lre a d y a v a ila b le a n d c o m m e rc ia liz e d . S o m e c o u n trie s, su c h a s C a n a d a a n d A u stra lia , a lre a d y re q u ire th a t a n e w d ru g b e sh o w n to b e e c o n o m ic a lly su p e rio r to its c o m p e tito rs.
H o w e v e r rig o ro u s th a t th e se n o rm s re g u la tin g th e a p p ro v a l o f p h a rm a c e u tic s m a y b e , th e y a re n o t e v e n c lo se to b e in g su ffic ie n t to g u a ra n te e c o m p le te sa fe ty to e a c h o f th e p a rtie s in v o lv e d . T h e a c t o f p re sc rib in g is e x tre m e ly c o m p le x a n d in v o lv e s th e u se o f in fo rm a tio n w h ic h m a y p a rtic u la riz e e a c h c lin ic a I c a se . F o r a d ru g to b e e v a lu a te d , it is n e c e ssa ry to h a v e a m in im u m o f in fo rm a tio n a v a ila b le to b a c k u p a n y a n a ly sis: it is n e c e ssa ry to h a v e v a lid , sc ie n tific e v id e n c e .
G e n e ra tin g th e e v id e n c e w h ic h p e rm its th e e v a lu a tio n o f th e e ffe c ti v e n e ss, e ffic a c y , a n d e ffic ie n c y o f th e d ru g is a lso c o m p le x o A t le a st th re e in te re ste d p a rtie s a lso . p a rtic ip a te in th is p ro c e ss: th e d ru g m a n u fa c tu re r, th e re se a rc h e r, a n d th e p a tie n t. In th is, th e p rin c ip a l c o m m o n in te re st is to c o n trib u te to th e a d v a n c e o f sc ie n c e ~ w h ile p ro v id in g p a tie n ts "a n d h e a lth p ro fe ssio n a ls a lik e w ith b e rte r m e a n s to re e sta b lish th e p h y sic a l, so c ia l a n d m e n ta l w e ll-b e in g o f th e p a tie n t. In th is p ro c e ss to o , o th e r in te re sts, c o m m o n to a ll th re e p a rtic ip a n ts o r n o t, m a y a lso b e p re se n t c o n sc io u sly o r u n c o n sc io u sly .
In th e g e n e ra tio n o f th is n e w k n o w le d g e , th e th re e p a rtie s m a k e in v e stm e n ts a n d in c u r risk s. T h e p a tie n t, b e in g su b m itte d to c lin ic a I re se a rc h , h o w e v e r e th ic a l a n d in fo rm e d , is n o t e x e m p t fro m risk s.
T h e re se a rc h e r, se rv in g h is o b je c tiv e o f p ro m o tin g th e a d v a n c e o f sc ie n c e , h a s th e re sp o n sib ility , a lo n g w ith th e m e d ic a I a n d n o n -m e d ic a I c o m m u n ity , to p la n , e x e c u te , a n d a n a Iy z e th ~ p ro p o se d re se a rc h in th e b e st p o ssib Ie w a y . T h e re se a rc h e r's in v e stm e n t a n d risk is d ire c tly lin k e d to th e re p e rc u ssio n s o f e a c h in v e stig a tio n , a n d to th e e ffe c ts o f its re su lts o n h is p ro fe ssio n a I c a re e r.
B e sid e s th e c o n c e rn s c ite d a b o v e , th e p h a rm a c e u tic a I in d u stry h a s a n in te re st in m a in ta in in g its "b u sin e ss", o r ra th e r, th e sa Ie o f a p ro d u c t th a t re q u ire d a g re a t in v e stm e n t a n d risk .
T h e p a tie n t, h o w e v e r in te re ste d in th e im p ro v e m e n t o f h is m e d ic a I c o n d itio n , in so m e in sta n c e s v a Iu e s th is c o n d itio n fo r th e in d ire c t g a in s it p ro v id e s. T h is fa c t c a n n o t b e n e g Ie c te d a n d sh o u Id b e e v a Iu a te d a n d p o n d e re d in te rm s o f th e re Ia tio n sh ip e sta b lish e d w ith th e re se a rc h e r a n d p h y sic ia n . T h e te n d e n c y o f p a tie n ts c o n sc io u sIy o r
F E R R A Z , M .S . - W h e n s h o u ld th e p h y s ic ia n q u e s tio n in fo rm a tio n d is s e m in a te d b y th e p h a rm a c e u tic a l in d u s try ?
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u n c o n sc io u sly to a p p e a se th e d e sire s o f re se a rc h e rs a n d p h y sic ia n s is w id e ly k n o w n a n d d o c u m e n te d .
A t th e c o n c lu sio n o f a re se a rc h p ro je c t, th e re se a rc h e r se ts fo rth n u m e ro u s re a so n s to p u b lish th e o b ta in e d re su lts. T h e se re a so n s m a y d iffe r fro m th e re a so n s th a t d ire c te d th e re a d e r to th is sc ie n tific m a te ria l. In o th e r w o rd s, th e m o tiv e s . b e h in d th e w ritin g o f a n a rtic le d o n o t a lw a y s c o in c id e w ith
re a so n s th a t ju stify th e re a d in g o f th is a rtic le .
It is im p o rta n t to b e a w a re th a t so m e tÍm e s re se a rc h e rs w rite a rtic le s w ith th e in te n tio n o f o b ta in in g re c o g n itio n , re sp e c t, o r fa m e in th e sc ie n tific w o rld , o r p e rh a p s to ju stify fu rth e r a rtic le s a n d n e w re se a rc h fm a n c in g . T h e se re a so n s a lo n e w o u ld ju stify n o t re a d in g a g o o d p ro p o rtio n o f p u b lish e d a rtic le s.
T o m a k e its "b u sin e ss" v ia b le , th e p h a rm a c e u tic a l in d u stry m u st d e fe n d its in te re sts, a lw a y s in a re sp o n sib le a n d e th ic a l w a y . S o m e fig u re s w ill illu stra te th e c o m m e rc ia l in te re sts w h ic h u n d e rsta n d a b ly a c c o m p a n y a n d stim u la te th e in v e stm e n ts o f th e d ru g in d u stry . F o r th e re se a rc h a n d d e v e lo p m e n t o f a n e w d ru g , fro m th e first stu d ie s w ith e x p e rim e n ta l, p h a rm a c o k in e tic a n d p h a rm a c o d y n a m ic m o d e ls u n til its a p p ro v a l a n d sa le , it is e stim a te d th a t a n a v e ra g e o f U S $ 1 0 0 -2 5 0 m illio n is in v e ste d p e r d ru g , in a p ro c e ss la stin g fro m 1 0 -1 5 y e a rs. B ra z iI is a m o n g th e to p 1 0 p h a rm a c e u tic a I m a rk e ts in th e w o rld , w ith a n a n n u a I tu rn o v e r o f U S $ 6 b illio n . H e re , th e in d u stry m a rk e ts o v e r 4 5 0 0 p ro d u c ts, a n d e m p lo y s m o re th a n 5 0 0 0 0 p e o p le . A s in o th e r d e v e lo p in g c o u n trie s, le ss th a n a q u a rte r o f th e B ra z ilia n p o p u la tio n c o n su m e s m o re th a n 6 0 p e rc e n t o f th e m e d ic a tio n s p ro d u c e d . T h e se fig u re s b y th e m se lv e s m a k e th e b u sin e ss o p p o rtu n itie s in th is se c to r c le a r.
B e sid e s th e re a so n s c ite d p re v io u sly , it is a Iso im p o rta n t th a t w e re ç o g n iz e th a t th e m e d ic a I e sta b lish m e n t, e v e n in d e v e lo p e d c o u n trie s, b u t p rin c ip a lly in d e v e lo p in g / c o u n trie s, is n o t a d e q u a te ly a w a re o f, o r tra in e d to v e rify ~
th e q u a lity o f p u b lic a tio n s, o r ra th e r, w h e th e r th e e v id e n c e p re se n te d is sc ie n tific a lly v a lid .
R e la te d to th is fa c t, it is w o rth h ig h lig h tin g th e sp e e d a t w h ic h n e w in fo rm a tio n a rise s. It is d iffic u lt fo r th e
S ão P aulo M edicai JournallR P M 115(4): 1467-1468, 1997
sp e c ia list to k e e p h im se lf u p -to -d a te . F o r e x a m p le , c o n sid e rin g th e y e a r 1 9 9 6 a n d c o n su ltin g M e d lin e fo r th e te rm s "rh e u m a to id a rth ritis", "sy ste m ic Iu p u s e ry th e m a to su s", a n d "N S A ID S ": re sp e c tiv e ly 1 4 3 9 , 7 4 0 , a n d 2 2 6 p u b lish e d a rtic le s w e re fo u n d a v a ila b le to th e m e d ic a I e sta b lish m e n t.
T o k e e p u p d a te d , th e p h y sic ia n m u st o p tim iz e h is re a d in g tim e . A u se fu I stra te g y is th e re je c tio n o f p o o r q u a lity a rtic le s, th u s a llo w in g a d e q u a te tim e fo r a m o re c a re fu l re a d in g o f fe w e r a rtic le s, p o te n tia lly v a lid sc ie n tific a lly a n d o f u se in h is d a ily m e d ic a I p ra c tic e .
N e v e rth e le ss, it is e x tre m e ly im p o rta n t th a t th e p h y sic ia n sh o u ld u se th e c o n c e p t o f e v id e n c e -b a se d m e d ic in e in h is d a ily w o rk . T o th is e n d , it is to b e h o p e d th a t th e re is c ritic a I e v a lu a tio n o f th e re se a rc h m e th o d o lo g y u tiliz e d in e v e ry a rtic le . In th e c a se o f a c lin ic a I tria l e v a lu a tin g th e e ffe c tiv e n e ss o r e ffic a c y o f a d ru g o r th e ra p e u tic in te rv e n tio n , it is fu n d a m e n ta l th a t th e fo llo w in g q u e stio n s b e a n sw e re d :
• W a s th e d iv isio n o f p a tie n ts in to tre a tm e n t g ro u p s tru ly ra n d o m iz e d ?
• W e re a ll th e c lin ic a ll y re le v a n t p a ra m e te rs e v a lu a te d ?
• W e re th e p a tie n ts stu d ie d re c o g n iz a b ly sim ila r to y o u rs?
• W e re c lin ic a I a n d sta tistic a l sig n ific a n c e c o n sid e re d ?
• Is th e th e ra p e u tic in te rv e n tio n e x e c u ta b le in y o u r e n v iro n m e n t?
• W e re a ll p a tie n ts w h o p a rtic ip a te d in th e stu d y c o n sid e re d in th e c o n c lu sio n s?
In c o n c lu sio n , a s re p re se n ta tiv e s o f th e ir p a tie n ts' in te re sts, p h y sic ia n s h a v e th e o b lig a tio n to p ro v id e in te rv e n tio n s re c o g n iz e d a s b e in g m o st e ffe c tiv e , e ffic a c io u s, a n d e ffic ie n t. T h e re fo re , a c ritic a I e v a lu a tio n o f th e m e th o d o lo g y o f a p u b lic a tio n m u st a lw a y s b e p e rfo rm e d , in d .e p e n d e n tly o f its so u rc e .
