homeopathiccp

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CENTER FOR INQUIRYTransnational

P.O. Box 741 Am herst , New York 14226-0741 (716) 636-4869 Fax (716) 636-1733 www.centerforinquiry net

Aug ust 26, 2011Division of Dockets Managem entFood and Drug Adm inist rat ionDepar tment of Heal th and H uman Serv ices5630 Fishers Lane, Rm. 1061Rockvil le , MD 20852

Citizen Petit ion to Require All OTC Hom eopathic Drugs to be Tested for Effectiveness and Labeled AccuratelyThe un dersigned subm it th is peti t ion on behalf of the Center for Inq uiry ("CFI") and i ts aff i lia te ,the Com mittee for Skeptical Inqu iry ("CSI"), pursuant to Federal Food and Drug Adm inistra tion("FDA " or "Agen cy") laws and regulations that require a ll comm ercia lly available drugs to beproven effect ive and be adequ ately labeled for their intended uses.CSI is a non profi t organization dedicated to promoting sc ientif ic inquiry an d cri t ica linvestigation, including cri t ica l investigation of c la ims re la t ing to unc onventional healthcarepractices, such as homeopathic m edicine . CSI 's advisors include a num ber of leading sc ientists,many of w hom are medica l spec ia lis ts . S ee ht tp : / /www.cs icop .o rg /abou t /cs i fellows and staff/.CFI is a n onprofi t organization supporting the activ i t ies of C SI, among other organizations.A . Action requestedThe undersigned hereby req uest the Comm issioner of Food and Drugs to in i t ia te a ru lemakingprocedure with a proposed rule: 1 . requiring a ll over-the-coun ter ("OTC") hom eopathic drugs tomeet the standards of effect iveness applicable to non-hom eopathic OTC drugs; and 2. requiringOTC homeopathic drugs n ot tested for effectiveness, and all advert isements for suc h drugs, toca rry a w arn ing labe l s ta t ing: "W AR NING: The FDA has no t de te rmined tha t th is p roduc t i ssafe, ef fect ive, and n ot misbranded for i ts intended use."B. Statement of grounds

1 .he Agency is authorized by law to take the action requested.Although the Ag ency has n ot yet done so, the Federal Food, Drug , and Cosmetic A ct (the "Act")permits the Agency to require OTC hom eopathic drugs to meet the same effectiveness standardsthat apply to other O TC drug s.F f_P


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S e c t i o n 5 0 5 (d ) o f t h e A c t r e q u i r e s " s u bs ta n t i a l e v id e n ce " o f e f f e c t iv e n e s s be f o r e a d ru g c a n bep la ce d o n t h e m a rk e t a n d s o ld t o co n s u m e r s . In m o s t i n s ta n ce s , t h e Ag e n cy h a s i n t e rp re t e d t h isto me a n th a t a d ru g m a n u f a c tu r e r m u s t p ro v id e a d e q u a t e a n d we l l - co n t ro l le d c l i n i c a l s tu d i e sd i s ti n g u i s h i n g a d ru g 's e f f e c t i v e n e s s "f ro m o th e r i n f l u e n ce s , s u ch a s s p o n ta n e o u s ch a n g e i n t h ecou rse o f the d isease , p lacebo e f fec t , o r b iased observa t ion ." 21 C.F .R . 314 .126 .T h e A c t 's l a n g u a g e m a k e s c l e a r t h a t h o me o p a th i c d ru g s f a l l u n d e r t h e d e f i n i ti o n o f t h e t e rm"drug" as used broadly in the Act. Section 201(g)(1) of the Act defines the term "drug" as usedin the Ac t to inc lude "a r t i c les recogn ized in the o f f i c ia l Uni ted S ta tes Pharm acop e ia ["USP"] , theo f f i c i a l Ho m e o p a th ic P h a rma c o p e i a o f t h e U n i t e d S t a te s [ " HP U S " ], o r o f f i c i a l Na t i o n a lF o rmu la ry [ " NF " ] , o r a n y s u p p le me n t t o t h e m ; a n d a r t i c le s i n t e n d e d f o r u s e i n t h e d i a g n o s i s ,cu re , mi t iga t ion , trea tme nt , o r the p reven t ion o f d i sease in man o r o ther an im als ; a r t i c les (o therth a n f o o d ) i n t e n d e d to a f f e c t th e s t r u c t u r e o r a n y f u n c t i o n o f t h e bo d y o f m a n o r o th e r a n ima l s ;a n d a r t i c l es i n t e n d e d f o r u s e a s a co m p o n e n t o f a n y a r t i c l e s" s o s p e c i f i e d . W h e th e r o r n o t t h e yare o f f i c ia l hom eopa th ic rem edies , those p roduc ts o f fe red fo r the cu re , mi t iga t ion , p reven t ion , o rt r e a tm e n t o f d i s e a s e co n d i t i o n s a r e r e g a rd e d a s d ru g s w i th i n t h e m e a n in g o f S e c t i o n 2 0 1 (g ) (1 ) o fthe Act.S e c t i o n 4 0 0 .4 0 0 o f th e F D A C o mp l ia n ce P o l icy G u id e l in e s , " C o n d i t io n s U n d e r W h ichHomeopathic Drugs May be Marketed," states that a product's "compliance with requirements oft h e HP U S , U S P , o r NF d o e s n o t e s t a b li s h t h a t i t h a s be e n s h o wn by a p p ro p r i a t e me a n s t o be s a f e ,e f fec t ive , and no t m isbranded fo r i t s in tended use ."T h e p l a i n me a n in g o f t h e Ac t t h e r e fo r e p e rmi t s th e Ag e n cy to s u b je c t OT C h o m e o p a th i c d ru g s tothe same e f fec t ivene ss s tandards tha t app ly to o ther OT C drug s .T h e A g e n cy h a s b ro a d a u th o r i ty o v e r t h e l a be li n g o f d ru g s . S ee Sect ion 502 o f the Act and 21C .F .R . P a r t 2 0 1 . T h ro u g h i t s r u le m a k in g a u th o r i t y , th e A g e n cy h a s r e q u i r e d bo th t e s ti n g f o re f fec t iven ess and approp r ia te labe l ing o f ce r ta in c lasses o f d rug s . E.g . , La be l ing andE f f e c t iv e n e s s T e s t in g ; S u n s c r e e n Dru g P ro d u c t s f o r Ov e r - th e -C o u n te r Hu m a n U s e , 7 6 F e d . R e g .35620 ( June 17 , 2011) .

2.he col lect ive weight of the scientif ic evidence establishes that homeopathicdrugs are no m ore effect ive than placebos.Ho m e o p a th i c d ru g s a r e i n e f f e c t iv e f o r a t l e a s t two i n d e p e n d e n t r e a s o n s , e i th e r o f w h i ch i ssu f f i c ien t to es tab l i sh homeo path ic d rug s ' ine f f i cac y in l igh t o f bas ic , we l l -es tab l i shed p r inc ip leso f b iochem is try and pharmaco logy .F i rs t , the re i s no re l iab le sc ien t i f i c ev iden ce tha t the a l leged ac t ive ing red ien ts in hom eopa th icd ru g s cu r e t h e d i s e a s e s a n d co n d i ti o n s f o r w h i ch t h e y a r e i n d i ca t e d . In d e e d , a s d i s cu s s e d f u r th e rbelow, homeopathic "theory" is premised on the magical notion that very small doses ofs u bs t an ce s t h a t c a u s e d i s e a s e s y mp to m s ca n a l le v i a te t h o s e s a me s y mp to m s .S e co n d , p ro d u c e r s o f h o m e o p a th ic d ru g s t y p i ca l ly d i l u t e t h e d ru g s ' a l le g e d a c t i v e i n g y e d i e n t s i nso lu t ion to the po in t tha t the so lu t ion con ta ins , on averag e , no t a s ing le molecu le o f the a l leged

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active ingredient.' In other words, what the producers and retailers of homeopathic drugs marketa s " me d i ca t i o n s " a r e n o th i n g m o re t h a n s o lu t i o n s t h a t a re d e v o id o f a c t i v e i n g r e d i e n ts ( o f t e n t h es o lu ti o n s a r e s imp ly w a te r ), wh i ch t h e n h a v e be e n co m b in e d w i th v a r io u s i n a c t i v e i n g r e d i e n t s ,such as b a l ls o f o rd inary sug ar .Ho m e o p a th y , wh i ch wa s d e v e lo p e d a n d p o p u la r i ze d in t h e l a te 1 8 th ce n tu ry by t h e G e rm a np h y s i c i a n S a m u e l H a h n e m a n n , p u rp o r ts t o s t imu la t e t h e bo d y ' s a b i li t y t o h e a l i ts e l f bya d min i s t e r in g v a n i s h i n g ly s ma l l d o s e s o f h i g h ly d i l u t e d s u bs t a n ce s . 2 Homeopathy is based ontwo p r i n c ip l e s , bo th o f w h i ch co n t r a d ic t ba s i c , we l l -e s t a b li s h e d l a ws o f m o d e rn ch e m is tr y a n dp h a rma c o lo g y : t h e " p ri n c ip l e o f s im i la r s ," wh i ch h o ld s th a t a d i s e a s e ca n be c u r e d by a s u bs t a n ceth a t p ro d u ce s s im i l a r s y mp to m s i n h e a l th y p e o p le ; a n d th e " p r i n c ip l e o f d i l u t io n s , " wh i ch h o ld stha t the low er the dose o f the m ed ica t ion , the g rea te r i t s e f fec t iveness . 3 Pursuant toHa h n e ma n n ' s t ea ch in g s , mo s t h o m e o p a th i c r e me d ie s s o ld to d a y h a v e be e n d i l u t e d r e p e a te d ly t othe ex ten t tha t no t a s ing le molecu le o f the a lleged hea l ing subs tanc e remain s .4As o n e w o u ld e x p e c t , t h e s c i e n t i fi c e v id e n ce e s t a b li s h e s t h a t a n y a p p a re n t be n e f i t s f r o mhom eopath ic d rugs a re mere p lacebo e f fec ts .The medical journal The Lancet p u b l i s h e d a co mp re h e n s iv e r e v i e w o f h o m e o p a th i c t re a tme n t s i n2005 . 5 The authors analyzed every clinical investigation then published on the effects ofhomeopathy. Their analysis identified 110 well-designed investigations into its effects. Ther e s u l ts o f t h o s e t r i a ls w e re t h e n co m p a re d to 1 1 0 w e l l-d e s ig n e d i n v e s t ig a t i o n s o f co n v e n t i o n a lme d i ca l t h e r a p i e s f o r th e s a m e a i lme n t s . T h e a u th o r s co n c lu d e d :

B ia s e s a r e p r e s e n t i n p l a ce bo - co n t ro l le d t r i a ls o f bo th h o m o e o p a th y a n d co n v e n t i o n a lme d i c i n e . W h e n a cc o u n t w a s t a k e n f o r t h e se b i a s e s in t h e a n a ly s i s , t h e r e wa s we a kHo m eopaths den o te a 1 - to -100 d i lu t ion by the le t te r "C," and a 1 - to -10 d i lu t ion by the le t te r"X." For example, a "6X" homeopathic preparation is a 1-to-10 dilution repeated six times,l e a v in g t h e a l le g e d a c t i v e i n g r e d ie n t a s o n e p a r t p e r m i ll io n . H o m e o p a th i c d ru g s d e s i g n a t e d a s2 4 X , 1 2 C o r h i g h e r co n t a i n , o n a v e ra g e , n o mo le cu l e s o f t h e o r i g in a l s u bs t a n ce f ro m w h i ch t h e y

were prepared. See generally S te h l in , I s a d o ra . " Ho m e o p a th y : r e a l me d i c i n e o r e m p typromises?" FDA C onsumer, De c . 1 9 9 6 . Av a i l a b le o n l i n e a th t tp : / / f indar t i c les .com/p/a r t i c les /mi_m1370/ i s_n10_v30/a i_18979004/ . 2 Na t io n a l I n s t it u t e s o f He a l th ( " NI H" ) N a t io n a l C e n te r f o r C o m p l im e n ta ry a n d Al t e rn a t iv eMedicine Backgrounder: Homeopathy, An Introduction (July 2009). Available online atht tp : / /nccam.n ih .gov/hea l th /homeopathy / . 3 I d .4 I d .

5 S h a n g A , H u w i le r -M i in t e n e r K , Na r t e y L , e t a l . "Are t h e c l in i c a l e f f e c t s o f h o mo e o p a th yp la ce bo e f f e c t s ? C o m p a ra t iv e s t u d y o f p l a ce bo - co n t ro l le d t r i a ls o f h o m o e o p a th y a n d a l l o p a th y . "Lancet 2005 ; 366: 726-732 . Ava i lab le on l ine a thttp : //www . thelanc e t . com /j ournals /lancet/ar t ic le /PIIS 0140-6736(05)67177 -2/fu l ltex t . (Attachedhere to as Exh ib i t A. )

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e v id e n ce f o r a s p e c i f i c e f f e c t o f h o m o e o p a th i c r e me d ie s , bu t s tr o n g e v id e n c e f o r s p e c i f i ceffects of conventional interventions. This finding is compatible with the notion that thec l in ica l e f fec ts o f homoeopa thy a re p lacebo e f fec ts .6T h e h ig h ly e s t e e me d C o ch ra n e C o l l a bo ra t i o n h a s p u b l i sh e d r e v i e ws o f h o m e o p a th i c t re a tme n t sf o r t h e tr e a tm e n t o f a n u mb e r o f d i s e a se s a n d m e d i ca l co n d i t io n s , i n c l u d in g , a mo n g o th e r s,d e me n t i a , ch ro n i c a s th m a , a t te n t i o n d e f i c i t h y p e ra c t iv i t y d i s o rd e r (AD HD ) , a n d i n f l u e n za . I ne a ch i n s t a n ce t h e r e v i e ws co n c lu d e d th a t e v id e n ce f o r h o m e o p a th i c d ru g s ' e f f i c a cy i sn o n e x i s t e n t , u n r e l ia b l e , o r to o s ca r ce t o wa r r a n t r e co m me n d a t i o n s r e g a rd in g h o m e o p a th ict rea tment . 7 Al th o u g h m o s t a n a ly s e s h a v e co n c lu d e d th a t th e r e i s l it tl e e v id e n ce t o s u p p o r t h o m e o p a th y a s a ne f fec t ive t rea tment fo r any spec i f i c con d i t ion , some s tud ies have repor ted pos i t ive f ind ing s .8Studies reportin positive findings, however, are generally poorly controlled and/or have notbeen repl icated.

6 I d .

7 See, e.g., M cC a rn e y , R .W . , et a l. , " Ho m e o p a th y f o r ch ro n i c a s th m a , " C o ch ra n e D a ta ba s e o fS y s t e ma t i c R e v i e ws 1 9 9 9 , I s su e 1 . A r t . No . : C D0 0 0 3 5 3 . D OI :10 .1002/14651858 .CD000353 .pub2 (ava i lab le on l ine a th t tp : / /www2.cochrane .o rg / rev iews/en /ab000353 .h tml) ; He i r s , M . a n d De a n , M .E. , " Ho m e o p a th yfor a t ten t ion de f ic i t /hyperac t iv i ty d i so rder o r hyperk ine t ic d i so rder ," Co chran e Database o fS y s t e ma t i c R e v i e ws 2 0 0 7 , I s su e 4 . A r t. No . : C D0 0 5 6 4 8 . D OI :10 .1002/14651858 .CD005648 .pub2 (ava i lab le on l ine a th t tp : / /www2.cochrane .o rg / rev iews/en /ab005648 .h tml) ; M cC a rn e y , R .W . , e t a l ., "Ho m e o p a th yf o r d e me n t ia , " C o ch ra n e D a ta ba s e o f S y s t e ma t i c R e v i e ws 2 0 0 3 , I s s u e 1 . Ar t . No . : C D 0 0 3 8 0 3 .DO I : 10 .1002/14651858 .CD 003803 (ava i lab le on l ine a th t tp : / /www2.cochrane .o rg / rev iews/en /ab003803 .h tml) ; Vickers , A. and Sm i th , C . ," Ho m o e o p a th i c Os c i l lo co cc i n u m f o r p r e v e n t in g a n d t r e a ti n g i n f l u e n za a n d i n f l u e n za - l i k es y n d ro m e s ," C o ch ra n e D a ta ba s e o f S y s t e ma t i c R e v i e w s 2 0 0 9 , Is s u e 3 . Ar t . No . : C D0 0 1 9 5 7 .DOI : 10 .1002/14651858 .CD001957 .pub4 (ava i lab le on l ine a th t tp : / /www2.cochrane .o rg / rev iews/en /ab001957 .h tml) . 8 NI H N a t io n a l C e n te r f o r C o m p l ime n ta ry a n d Al te rn a t i v e M e d i c i n e B a ck g ro u n d e r :Ho m e o p a th y , An I n t ro d u c t i o n ( J u ly 2 0 0 9 ) . Av a i l a b le o n l i n e a thttp ://ncc am. nih. goy/health/homeopathy/.9 F o r e x a m p le , a 1 9 9 7 m e ta - a n a ly s i s o f p l a ce bo - co n t ro ll e d t r ia l s o f h o m e o p a th i c d ru g s co n c lu d e dth a t p a ti e n t s r e ce iv in g h o m e o p a th i c d ru g s w e re m o re l i k e ly t h a n p a t ie n t s r e ce iv i n g p l a ce bo s t os h o w s i g n s o f im p ro v e me n t . L in d e , K ., e t a l ., " Are t h e c l in i c a l e f f e c t s o f h o m e o p a th y p l a ce boef fec ts? A m eta -ana lys i s o f p lacebo-c on t ro l led t r ia l s . " Lancet, 1997; 350 (9081): 834-43.Av a i l a b le o n l in e a t h t tp : //www .n cb i .n lm .n ih .g o v /p u bm e d /9 3 1 0 6 0 1 . T h e a u th o rs o f t h e r e po r tl a te r r e - e x a min e d th e ir m e ta - a n a ly s i s . In a f o l l o w-u p p a p e r t h a t a c co u n te d f o r n e w, h i g h -q u a l it yt r ia ls show ing n ega t ive resu l t s , the au tho rs conc luded tha t " in the s tudy se t inves t iga ted , the rew as c lea r ev idence tha t s tud ies wi th be t te r method olog ica l qu a l i ty tende d to y ie ld less pos i t iveresu l t s . . . I t seems l ike ly , the re fo re , tha t our [1997] m eta -ana lys i s a t leas t over -es t imated the

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T h e co l l e c t iv e w e ig h t o f s c i e n t if i c e v id e n ce d e m o n s t r a te s t h a t h o me o p a th i c d ru g s y i e ld n obenefit beyond the placebo effect. In addition, the premise upon which the effectiveness of" h o me o p a th i c m e d i c i n e " i s f o u n d e d th a t h i g h ly d i l u t e d p r e p a ra ti o n s o f s u bs t a n ce s t h a t c a u s es y m p to ms i n h e a l th y i n d iv id u a l s w i l l r e d u ce s im i la r s y m p to ms i n p a t ie n t s h a s n o b a s i s inrea l i ty and has been d isp roved repea ted ly . 1 Acco rd in g ly , m a jo r h e a l th a n d m e d i ca lo rg a n i za t io n s , i n c l u d in g t h e Am e r i ca n M e d i ca l As s o c i a t io n , h a v e co n c lu d e d th a t t h e r e is n oco n v in c i n g s c i e n t if i c e v id e n ce t o s u p p o r t t h e u s e o f h o me o p a th i c t r e a tme n t s in m e d i c i n e . "

3.he Agency's failure to regulate homeopathic products has enabled a multi-m illion dol lar industry to mar ket ineffect ive products to unsusp ecting, i l lconsumers.Al th o u g h th e A g e n cy h a s t h e a u th o r it y t o r e q u i r e h o me o p a th i c p ro d u c t s t o u n d e rg o th ee f fec t iven ess tes t ing tha t app l ies to p rescr ip t ion an d new O TC d rugs , i t has to da te dec l ined toexercise that authority. The Agency's permissive regulatory policy has enabled the growth of am u l t i-mi l li o n d o l l a r ma rk e t f o r p ro d u c t s f o r w h i ch t h e r e i s n o c r e d ib le s c i e n t i f ic e v id e n c e o fe f fec t iveness beyon d what i s expec ted f rom the p lacebo e f fec t .Con sum er sa les o f hom eopa th ic t rea tments in the U.S . reached $870 mi l l ion in 2009 .12Ac co rd in g t o a 2 0 0 7 s t u d y co n d u c t e d by t h e C e n te r f o r D i s e a s e C o n t ro l a n d P re v e n t i o n( " C DC " ) , a n e s t im a te d 3 .9 mi l l io n U .S . a d u l t s a n d a p p ro x ima te ly 9 0 0 ,0 0 0 ch i ld r e n u s e dh o m e o p a th i c p ro d u c t s i n t h e p r e v io u s y e a r . 1 3 Ill consumers who desire effective medicalt r e a tm e n t t u rn , u n w i tt i n g ly , to h o m e o p a th i c d ru g s , u s i n g t h e m f o r a b ro a d r a n g e o f h e a l thco n c e rn s , i n c l u d in g t h e t r e a tme n t o f d i s e a s e s a n d co n d i t io n s s u c h a s a l l e rg ie s , a s th m a , ch ro n i cfa t igue syn drom e, depress ion , d iges tive d iso rders , ea r in fec t ions , headaches , and sk in rashes .14e f f e c t s o f h o me o p a th i c t r e a tme n t s ." L in d e , K . , e t a l . "I mp a c t o f S tu d y Q u a l i t y o n O u t co m e i nP la ce bo -C o n t ro l le d T r i a ls o f Ho m e o p a th y , " Jo u rn a l o f C l i n i c a l E p id e m io lo g y 1 9 9 9 :5 2 (7 ) : 6 3 1 6. Available online at http://www.ncbi.nlm.nih.gov/pubmed/10391656 (At tached here to asExhibit B.)1 1 3 S ee, e.g., E rn s t, E . "A s y s t e ma t i c r e v i e w o f s y s t e ma t i c r e v i e ws o f h o m e o p a th y , " B r . J. C l i n .P h a rma c o l . V .5 4 (6 ) : 5 7 7 -5 8 2 (De c . 2 0 0 2 ) . Av a i l a b le o n l in e a th t t p : / /www.n cb i . n lm .n ih .g o v /p u bme d /1 2 4 9 2 6 0 3 . (At tached here to as Exh ib i t C . )1 1 AM A C o u n c i l o n S c i e n t i f i c Af f a i r s. "A l t e rn a t iv e M e d i c i n e : R e p o r t 1 2 o f t h e C o u n c i l o nS c i e n t i f ic A f f a i rs (A-9 7 ) " p a g e 8 . Am e r i ca n M e d i ca l As s o c i a ti o n (1 9 9 7 ) .1 2 "Homeopathy prospers even as controversy rages." J. Deardorff, Chicago Tribune, March 6,2011. Available online at http://articles.chicagotribune.com/2011-03-06/news/ct-met-0306- h o me o p a th y -2 0 1 1 0 3 0 6 _1 _h o me o p a th y -o sc i l lo co cc i n u m -p ro d u c t s.1 3 NI H N a t io n a l C e n te r fo r C o m p l ime n ta ry a n d Al te rn a t iv e M e d i c i n e B a c k g ro u n d e r :Ho m e o p a th y , An I n t ro d u c t i o n ( J u ly 2 0 0 9 ) . Av a i l a b le o n l i n e a th t tp : / /nccam.n ih .gov/hea l th /homeopathy / . 1 4 Id.

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Ho m e o p a th i c d ru g s a r e t y p i ca l ly m a rk e t ed i n w a y s t h a t l e a d co n s u m e r s t o be li e v e t h a t th e y a r ee f f e c t iv e f o r p r e v e n t i n g a n d t r e a ti n g i l ln e s s e s a n d s y m p to ms , s o me o f w h i ch ca n l e a d t o s e v e recom pl ica t ions , hosp i ta l iza tion , o r dea th i f im proper ly t rea ted .B y wa y o f e x a m p le , th e r e t a i l g ia n t W a l -M a r t S to r e s, I n c . ( " W a l -M a r t " ) p ro mo te s t h e s a l e o f t h eh o m e o p a th ic d ru g B o i ro n Os c i l lo co cc i n u m , a h o me o p a th i c d ru g p ro d u ce d by B o i ro n U S A("Boiron"), through Wal-Mart's website, www.walmart.com . The webs i te ind ica tes tha t Bo i ronOs c i l l o co cc i n u m i s i n d i ca t e d f o r t h e t re a tme n t o f " f lu - l ik e s y m p to ms . " 1 5 The website 1 6 alsof e a tu r e s a n ima g e o f t h e p ro d u c t ' s p a ck a g e , wh i ch i n d i ca t e s t h a t th e p ro d u c t " R e d u ce s [ t h e ]Du ra t io n a n d S e v e r i ty o f F lu S y m p to ms , " i n c l u d in g " F e v e r , C h i l ls , B o d y A ch e s a n d P a in s ."Bo i ron i t se lf i s even bo lder , enga g ing in a dver t i s ing tha t i s h igh ly mis lead ing a s i t seeks tos u g g e s t t h i s Ag e n c y h a s a p p ro v e d i t s p ro d u c t . B o r io n 's we bs i t e f o r Os c i l lo co cc i n u m ,h t tp : / /www.osc i l lo .com/abou t / fac ts -abou t -osc i l lo , ma in ta ins tha t four c l in ica l s tud ies show thee f fec t iven ess o f i ts p roduc t , and th i s c la im i s then imm edia te ly fo l low ed by the asse r t ion tha t"Osc i l lo com pl ies w i th a w el l -es tab l i shed f ramew ork o f gu ide l ines , regu la t ions , and q ua l i tys tandards es tab li shed by the FD A."C o n s u m e r s u n d o u b te d ly p u r ch a s e t h e p ro d u c t ba s e d o n W a l -M a r t 's a n d B o i ro n s a s s u r a n ce s t h a tB o i ro n O s c i ll o co cc i n u m i s , in f a c t , e f fe c t i v e f o r p r e v e n t in g a n d t r e a t in g t h e f l u e s p e c i a ll y a sBoi ron im pl ies i t s p roduc t has been tes ted by th i s Ag enc y .Y et there i s no c red ib le sc ien t i f i c ev idenc e to suppo r t the e f fec t ivene ss o f Bo i ronOs c i l l o co cc i n u m be y o n d w h a t i s e x p e c t e d f ro m th e p l a ce bo e f f e c t . 1 7 This is hardly surprising, asB o i ro n O s c i ll o co cc i n u m 's a l le g e d i n g re d i e n t l iq u e f i e d d u ck l iv e r a n d h e a r t wa s m i s ta k e n lyiden t i f ied in the ea r ly 20 th cen tu ry as a poss ib le home opa th ic agen t on the bas i s o f the fa l se

1 5 See http://www.walmart com/ip/Boiron-Oscillococcinum-Homeopathic-Flu-Medicine-6c t /10316942#Produc tDe ta i l .16 W a l-M a r t 's m i s le a d in g p ro m o t io n o f t h i s h o me o p a th i c d ru g a s a t r e atme n t f o r f l u i s n o tl im i t e d t o t h e we bp a g e o n wh i ch t h e p ro d u c t i s d i s p la y e d . C o n s u m e r s w i l l re a ch t h i s p a g e o n lyafter visiting Wal-Mart's "Medicine Cabinet" page, http://www.walmart.com/cp/Medicine-C a b in e t /9 7 6 7 9 8 , wh i ch a s s u r e s cu s to m e r s t h a t th e p ro d u c t s W a l -M a r t c a r r ie s w i ll " f ig h t co ld sand the f lu ." F rom there , web s i te v i si to rs wi l l nav iga te to the "Cou gh , Colds & F lu W el lnessShop" page , h t tp : / /hea l th .walmar t .com/hea l th - t ips /cough-co ld - f lu /20 , wh ich p rom ises to he lp thecu s to me r " S ta y o n t o p o f co ld a n d f l u s e a s o n by l e a rn i n g a bo u t p ro d u c t s th a t c a n h e lp y o u a n dy o u r f a m i ly s t a y w e l l, r e li e v e s y m p to ms a n d r e co v e r f a s t. " In i t s " C o u g h , C o ld , a n d F lu B u y in gGuide ," h t tp : / /hea l th .walmar t .com/hea l th -adv ice /cough-co ld - f lu -buy ing-gu ide /689/ , Wal-Mar ta s s e rt s t h a t it s p ro d u c t s w i l l p ro v id e t h e cu s to me r " w i th e v e ry th in g y o u a n d y o u r f a m i ly n e e d f o rbatt l ing a cold or the f lu ."1 7 G u o , R . , e t a l. , " C o m p le me n ta ry M e d i c i n e f o r T re a t in g o r P r e v e n t i n g I n f l u e n za o r I n f l u e n za -like Illness," Am. J. Med., Vol. 120 Issue 11, 923-929 (2007). Available online ath t tp : //www .a mjme d . co m/a r t ic l e /S 0 0 0 2 -9 3 4 3 % 2 8 0 7 % 2 9 0 0 8 7 6 -5 /a bs t ra c t .

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be l ie f tha t i t con ta ined "osc i l lococ c i , " microscop ic b ac te r ia tha t p roved to be im ag inary .18M o re o v e r , li k e m o s t p ro d u ce r s o f h o m e o p a th ic d ru g s , B o i ro n d i l u t e s i ts a l le g e d a c t iv e i n g r e d i e n tto the po in t tha t the like l ihood tha t even a s ing le molec u le o f the subs tanc e rema ins i s1 9van i sh ing ly sm a l l.

T h e h o m e o p a th i c i n d u s t ry ' s ma rk e t i n g o f h o m e o p a th i c d ru g s , a id e d by m a jo r r e t a il e rs s u ch a sWal-Mart, is a profound disservice to the public. Beyond leading consumers to squanderh u n d re d s o f m i ll io n s o f d o l l a r s a n n u a l l y o n i n e f f e c t i v e r e me d ie s , h o me o p a th i c d ru g p ro d u ce r sand re ta i le rs p lace the pu bl ic hea l th a t r i sk by d isp lac ing p roven , e f fec t ive med ic a l t rea tm ents .I n f luenz a , fo r exam ple , is a se r ious i llness tha t can lead to com pl ica t ions resu l t ing inh o s p i ta l iz a t io n o r e v e n d e a th , e s p e c i al ly a m o n g th e e ld e r ly , t h e v e ry y o u n g , a n d i n d iv id u a l s w i thcer ta in hea l th cond i t ions . 2 Ye t U .S . s a le s o f t h e w h o l ly i n e f f e c t iv e h o m e o p a th i c f l u r e me d yOsc i l lococc inu m reached $15 mi l l ion in 2008 a lone .21T h e A g e n cy s h o u ld a c t t o e n s u re t h a t co n s u m e r s a r e n o t l e d t o be li e v e t h a t e ff e c t i v e p r e v e n t iv ea n d th e r a p e u t i c me a s u re s c a n be i g n o re d i n f a v o r o f p ro d u c t s t h a t a mo u n t t o m e re p l a ce bo s , a tbest.

4.s the Age ncy reco gnizes, accurate label ing is crit ical i fconsumers are to mak e an informed choice .As d e m o n s t r a te d by t h e A g e n cy ' s r e ce n t l y i s su e d r u l e o n l a be l in g o f s u n s c r e e n p ro d u c t s ,L a be l i n g a n d E f f e c t i v e n e s s T e s t in g ; S u n s c r e e n Dru g P ro d u c t s f o r Ov e r - th e -C o u n te r Hu m a n U s e ,7 6 F e d . R e g . 3 5 6 2 0 ( J u n e 1 7 , 2 0 1 1 ) , t h is A g e n cy r e co g n i ze s i t s r e sp o n s ib i li t y t o e n s u re t h a tco n s u m e r s a r e p ro v id e d w i th a l l ma te r i a l i n f o rma t io n r e g a rd in g a p ro d u c t s o t h e y ca n ma k e a ni n f o rme d ch o i ce . T h e c h o i ce o f a s u n s c r e e n ca n be v e ry imp o r t a n t . A t l e a st e q u a l l y imp o r t a n t ,h o we v e r , a r e ch o i ce s r e l a t in g t o t h e t r e a tm e n t o f s e r i o u s d i s e a s e s s u ch a s i n f l u e n za . H o m e o p a th i cd ru g p ro d u c e r s a n d r e t a i le r s a r e m i s le a d in g co n s u m e r s i n to be l ie v i n g t h a t t h e i r p ro d u c t s a r ee f f e c t iv e . As i n d i ca t e d by B o i ro n ' s p ro mo t io n o f Os c i l lo co cc i n u m , ma n u f a c tu r e r s o fh o m e o p a th ic p ro d u c t s a r e n o t a v e r s e t o im p ly i n g t h a t t h is Ag e n cy h a s a p p ro v e d th e i r p ro d u c t .

1 8 Nienhuys, J. "The True Story of Oscillococcinum" (2003). Available online atht tp : / /www.homeowatch .o rg /h is to ry /osc i l lo .h tml . 1 9 B o i ro n O s c i ll o co cc i n u m u s e s a " 2 0 0 C " h o m e o p a th ic p r e p a ra t io n , i n d i ca t in g a 1 - to -1 0 0dilution repeated two hundred times. By way of comparison, a mere "30C" preparation is sod i lu t e t h a t a s i n g l e mo le cu l e o f t h e o r i g i n a l s u bs ta n ce d i s s o lv e d w o u ld o ccu p y a v o lu me o fsolution that is more than 30 billion times the size of the earth. S ee Barre t , S . "Hom eopathy : TheUltimate Fake." Available online ath t tp : / /www.q u a ck wa tch .o rg /0 1 Q u a ck e ry R e la t e d T o p i c s /h o me o .h tml . 2 9 See , e.g., C e n te r s f o r D i s e a s e C o n t ro l a n d P re v e n t io n , " S e a s o n a l I n f l u e n za : T h e D i s e a se . "Available online at http://www.cdc.gov/flu/about/disease/. 21 Park , Robe r t L . "Su pers t i t ion : Be l ie f in the Age o f Sc ience ," P r inc e ton Univers i ty P ress . ed . ,pp . 146 (2008) .

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Ho m e o p a th i c ma n u f a c tu r e r s a n d d i s t ri bu to r s k n o w th a t ( a s o f n o w ) t h e i r p ro d u c t s a r e n o t t e s t e df o r e f f e c t iv e n e s s by t h i s Ag e n cy ; t h i s Ag e n c y o bv io u s ly k n o w s th is a s we l l ; mo s t co n s u m e r s ,h o we v e r , a r e n o t a w a re o f t h i s f a c t . G iv e n t h i s Ag e n cy ' s we l l -d e se rv e d r e p u t a t io n f o r v i g o ro u sp ro t e c t io n o f A m e r i ca n co n s u m e r s , u n d o u b te d ly m o s t co n s u m e r s be li e v e th a t th i s Ag e n c yre q u i r e s h o me o p a th i c d ru g s t o m e e t t h e s a me e f f e c t iv e n e s s s t a n d a rd s a s co n v e n t io n a l , a ll o p a th i cmedicat ion.T o e n s u re t h a t co n s u m e r s a r e p ro p e rl y i n f o rme d , u n t i l su ch t ime a s a h o m e o p a th i c d ru g h a s be e na d e q u a t e l y t e s t e d f o r e f f e c t iv e n e s s , t h is A g e n cy s h o u ld r e q u i r e p a ck a g e s a n d a d v e r t i s e me n t s f o rhomeopathic drugs to bear a warning label stating: "WARNING: The FDA has not determinedtha t th i s p roduc t i s sa fe , e f fec t ive , and no t misbran ded fo r i t s in tended u se ."

C . Environmenta l impactNo th in g r e q u e s t e d in t h i s p e t it i o n w i l l h a v e a n im p a c t o n t h e e n v i ro n m e n t .D . Econom ic impactT h e o n ly p o t e n t i a l lo s s o f i n co m e th a t m ig h t r e s u l t f r o m th e r e q u e s t e d a c t i o n i s t o t h emanufacturers and distributors of OTC homeopathic drugs. There would be savings of up to$ 8 7 0 mi l l io n t o co n s u m e r s i f Ag e n cy t e s ti n g o f h o m e o p a th i c d ru g s e s ta b l is h e d th e y we rei n e f f e c t iv e a n d s u c h d ru g s w e re t o be r e mo v e d f ro m th e ma rk e tp l a ce . I n a d d i t io n , a ni n d e t e rmin a t e a mo u n t o f e co n o m ic be n e f i t wo u ld a cc ru e , t o in d iv id u a l p a ti e n t s a n d th e eco n o m yas a whole , f rom s ick persons ceas ing to re ly on ine f fec t ive d rugs .E . CertificationThe u nders ign ed ce r t i fy tha t , to the bes t know ledge and be l ie f o f the und ers igned , th i s pe t it ioninc lud es a l l in fo rm at ion and v iew s on wh ich the pe t i t ion re l ies , and tha t i t inc lud es represen ta t ived a t a a n d i n f o rma t io n k n o w n to t h e u n d e r s i g n e d w h i ch a r e u n f a v o ra b le t o th e p e t i ti o n .

Rona A. Lindsay, Pt & CEOCen te r fo r Inqu i ry3965 Rensch RoadAm hers t, NY 14226(716) 636-4869 ext . 215

Barry Karr , Ex t ive DirectorCom mit tee fo r Skep t ica l I nqu i ry3 9 6 5 R e n s c h R o a dAm hers t, NY 14226(716) 636-4869 ex t . 2178


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