{"id":82511,"date":"2025-07-01T00:14:07","date_gmt":"2025-06-30T22:14:07","guid":{"rendered":"https:\/\/www.infokuryr.cz\/n\/?p=82511"},"modified":"2025-06-30T12:05:31","modified_gmt":"2025-06-30T10:05:31","slug":"fda-pod-palbou-kritiky-stovky-leku-schvalenych-bez-prokazani-ucinnosti-pacienti-jako-pokusni-kralici-je-postizena-i-evropa","status":"publish","type":"post","link":"https:\/\/www.infokuryr.cz\/n\/2025\/07\/01\/fda-pod-palbou-kritiky-stovky-leku-schvalenych-bez-prokazani-ucinnosti-pacienti-jako-pokusni-kralici-je-postizena-i-evropa\/","title":{"rendered":"FDA pod palbou kritiky: Stovky l\u00e9k\u016f schv\u00e1len\u00fdch bez prok\u00e1z\u00e1n\u00ed \u00fa\u010dinnosti \u2013 pacienti jako pokusn\u00ed kr\u00e1l\u00edci \u2013 je posti\u017eena i Evropa?"},"content":{"rendered":"
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P\u0159esto\u017ee je FDA (FDA) americk\u00fdm \u00fa\u0159adem pro kontrolu l\u00e9\u010div, jeho rozhodnut\u00ed maj\u00ed velk\u00fd v\u00fdznam i pro Evropu. Mnoho l\u00e9k\u016f schv\u00e1len\u00fdch v Evrop\u011b je zalo\u017eeno na stejn\u00fdch studi\u00edch nebo je schv\u00e1len\u00edm FDA podpo\u0159eno. Evropsk\u00e9 org\u00e1ny, jako je EMA (Evropsk\u00e1 agentura pro l\u00e9\u010div\u00e9 p\u0159\u00edpravky), se nav\u00edc \u010dasto \u0159\u00edd\u00ed americk\u00fdmi regula\u010dn\u00edmi standardy \u2013 zejm\u00e9na v urychlen\u00fdch schvalovac\u00edch postupech. N\u00e1sleduj\u00edc\u00ed odhalen\u00ed o systematick\u00fdch nedostatc\u00edch FDA proto vyvol\u00e1vaj\u00ed v\u00e1\u017en\u00e9 ot\u00e1zky pro evropsk\u00e9 pacienty, l\u00e9ka\u0159e a \u00fa\u0159ady.<\/span><\/em><\/p>\n

Americk\u00fd \u00da\u0159ad pro kontrolu potravin a l\u00e9\u010div (FDA) schv\u00e1lil v posledn\u00edch letech stovky l\u00e9k\u016f, ani\u017e by adekv\u00e1tn\u011b otestoval jejich \u00fa\u010dinnost \u2013 a v n\u011bkter\u00fdch p\u0159\u00edpadech dokonce navzdory d\u016fkaz\u016fm o jejich \u0161kodlivosti. Toto je zji\u0161t\u011bn\u00ed dvoulet\u00e9ho a explozivn\u00edho vy\u0161et\u0159ov\u00e1n\u00ed l\u00e9ka\u0159sk\u00fdch novin\u00e1\u0159ek Jeanne Lenzerov\u00e9 a Shannon Brownleeov\u00e9, kter\u00e9 zve\u0159ejnil investigativn\u00ed port\u00e1l The Lever.<\/span><\/p>\n

Syst\u00e9m ve voln\u00e9m p\u00e1du<\/span><\/strong><\/h3>\n

Mezi lety 2013 a 2022 auto\u0159i p\u0159ezkoumali v\u00edce ne\u017e 400 schv\u00e1len\u00ed FDA. V\u00fdsledky jsou alarmuj\u00edc\u00ed: 73 procent l\u00e9k\u016f nespl\u0148ovalo z\u00e1kladn\u00ed krit\u00e9ria \u00fa\u010dinnosti. Pouze 28 procent spl\u0148ovalo v\u0161echny \u010dty\u0159i v\u011bdeck\u00e9 standardy FDA. \u010cty\u0159icet l\u00e9k\u016f nespl\u0148ovalo \u017e\u00e1dn\u00e9 z t\u011bchto krit\u00e9ri\u00ed.<\/span><\/p>\n

Nejde o byrokratick\u00e9 detaily, ale o z\u00e1kladn\u00ed principy: kontroln\u00ed skupiny, replikace, zaslepen\u00ed a klinick\u00e9 c\u00edlov\u00e9 parametry maj\u00ed zajistit bezpe\u010dnost pacient\u016f. Pod rostouc\u00edm vlivem politik\u016f a farmaceutick\u00e9ho pr\u016fmyslu v\u0161ak FDA tyto standardy st\u00e1le \u010dast\u011bji opou\u0161t\u011bla \u200b\u200bve prosp\u011bch tzv. \u201eregula\u010dn\u00ed flexibility\u201c.<\/span><\/p>\n

Sliby m\u00edsto d\u016fkaz\u016f<\/span><\/strong><\/h3>\n

Od 90. let 20. stolet\u00ed se FDA st\u00e1le v\u00edce spol\u00e9h\u00e1 na zrychlen\u00e9 schvalovac\u00ed postupy. Spole\u010dnosti mohou uv\u00e1d\u011bt l\u00e9ky na trh d\u0159\u00edve, ne\u017e bude prok\u00e1z\u00e1na jejich \u00fa\u010dinnost \u2013 se slibem, \u017ee pozd\u011bji p\u0159edlo\u017e\u00ed dal\u0161\u00ed studie. T\u00e9m\u011b\u0159 polovina t\u011bchto n\u00e1sledn\u00fdch studi\u00ed v\u0161ak nikdy nen\u00ed dokon\u010dena. A mnoho z t\u011bch, kter\u00e9 jsou dokon\u010deny, neposkytuje \u017e\u00e1dn\u00e9 d\u016fkazy o \u00fa\u010dinnosti \u2013 a p\u0159esto l\u00e9ky z\u016fst\u00e1vaj\u00ed schv\u00e1leny.<\/span><\/p>\n

\u201eToto je tich\u00fd posun paradigmatu,\u201c \u0159\u00edkaj\u00ed Lenzer a Brownlee. \u201eAni l\u00e9ka\u0159i, ani pacienti nebyli informov\u00e1ni.\u201c<\/span><\/p>\n

L\u00e9ka\u0159stv\u00ed proti rakovin\u011b: P\u00e1d \u010dlov\u011bka<\/span><\/strong><\/h3>\n

Situace je obzvl\u00e1\u0161t\u011b do o\u010d\u00ed bij\u00edc\u00ed v onkologii. Pouze t\u0159i ze 123 l\u00e9k\u016f proti rakovin\u011b v letech 2013 a\u017e 2022 spl\u0148ovaly v\u0161echna \u010dty\u0159i krit\u00e9ria FDA. 81 procent z nich bylo schv\u00e1leno na z\u00e1klad\u011b z\u00e1stupn\u00fdch m\u011b\u0159\u00edtek, jako je zmen\u0161en\u00ed n\u00e1doru \u2013 bez d\u016fkaz\u016f o prodlou\u017een\u00e9m p\u0159e\u017eit\u00ed nebo zlep\u0161en\u00ed kvality \u017eivota.<\/span><\/p>\n

Jeden p\u0159\u00edklad: Copiktra. Schv\u00e1leno pro l\u00e9\u010dbu rakoviny krve v roce 2018, proto\u017ee zlep\u0161ilo p\u0159e\u017eit\u00ed bez progrese. N\u00e1sledn\u00e9 anal\u00fdzy v\u0161ak uk\u00e1zaly, \u017ee pacienti u\u017e\u00edvaj\u00edc\u00ed Copiktru zem\u0159eli v pr\u016fm\u011bru o 11 m\u011bs\u00edc\u016f d\u0159\u00edve ne\u017e pacienti u\u017e\u00edvaj\u00edc\u00ed srovn\u00e1vac\u00ed terapii. Varov\u00e1n\u00ed od FDA p\u0159i\u0161lo a\u017e o \u0161est let pozd\u011bji.<\/span><\/p>\n

Elmiron \u2013 l\u00e9k bez p\u0159\u00ednosu a s vysok\u00fdm rizikem<\/span><\/strong><\/h3>\n

Elmiron byl schv\u00e1len k l\u00e9\u010db\u011b bolesti mo\u010dov\u00e9ho m\u011bch\u00fd\u0159e v roce 1996 \u2013 na z\u00e1klad\u011b \u201eprakticky nulov\u00fdch\u201c \u00fadaj\u016f. Povinn\u00e1 n\u00e1sledn\u00e1 studie nebyla provedena po dobu 18 let. Kdy\u017e byla kone\u010dn\u011b dokon\u010dena, uk\u00e1zala, \u017ee Elmiron nebyl \u00fa\u010dinn\u011bj\u0161\u00ed ne\u017e placebo.<\/span><\/p>\n

Mezit\u00edm stovky pacient\u016f trp\u011bly z\u00e1va\u017en\u00fdmi vedlej\u0161\u00edmi \u00fa\u010dinky, jako je ztr\u00e1ta zraku a z\u00e1n\u011bt tlust\u00e9ho st\u0159eva \u2013 n\u011bkte\u0159\u00ed dokonce zem\u0159eli. L\u00e9k je v\u0161ak st\u00e1le na trhu. L\u00e9ka\u0159i jej nad\u00e1le p\u0159edepisuj\u00ed. Americk\u00e1 urologick\u00e1 asociace jej dokonce uv\u00e1d\u00ed jako jedin\u00fd schv\u00e1len\u00fd l\u00e9k na toto onemocn\u011bn\u00ed.<\/span><\/p>\n

\u201eVis\u00edc\u00ed schv\u00e1len\u00ed\u201c \u2013 \u010dekaj\u00edc\u00ed schv\u00e1len\u00ed<\/span><\/strong><\/h3>\n

FDA si je probl\u00e9mu v\u011bdoma \u2013 m\u00e1 pro to sv\u016fj vlastn\u00ed term\u00edn: \u201evis\u00edc\u00ed schv\u00e1len\u00ed\u201c. V\u00fdrazn\u00fdm p\u0159\u00edkladem je Avastin. Schv\u00e1leno v roce 2008 pro metastazuj\u00edc\u00ed rakovinu prsu na z\u00e1klad\u011b nevalidovan\u00e9ho n\u00e1hradn\u00edho c\u00edlov\u00e9ho parametru. Pozd\u011bj\u0161\u00ed studie neprok\u00e1zaly \u017e\u00e1dn\u00fd p\u0159\u00ednos pro p\u0159e\u017eit\u00ed a z\u00e1va\u017en\u00e9 vedlej\u0161\u00ed \u00fa\u010dinky. FDA schv\u00e1len\u00ed st\u00e1hla \u2013 ale negativn\u00ed reakce byla masivn\u00ed. Farmaceutick\u00e9 spole\u010dnosti a pacientsk\u00e9 organizace organizovaly kampan\u011b, zam\u011bstnanci FDA byli vyhro\u017eov\u00e1ni a policie musela budovu chr\u00e1nit. Od t\u00e9 doby FDA nevynutila dal\u0161\u00ed ne\u017e\u00e1douc\u00ed sta\u017een\u00ed schv\u00e1len\u00ed.<\/span><\/p>\n

Promarn\u011bn\u00e9 miliardy \u2013 ohro\u017een\u00ed \u017eivot\u016f<\/span><\/strong><\/h3>\n

Jen mezi lety 2018 a 2021 zaplatily Medicare a Medicaid 18 miliard dolar\u016f za l\u00e9ky schv\u00e1len\u00e9 na z\u00e1klad\u011b n\u00e1sledn\u00e9 studie. Mnoho z t\u011bchto studi\u00ed nebylo nikdy dokon\u010deno.<\/span><\/p>\n

\u0160kody v\u0161ak nelze kvantifikovat pouze v pen\u011b\u017en\u00edm vyj\u00e1d\u0159en\u00ed. Studie z roku 2015 uk\u00e1zala, \u017ee 86 procent onkologick\u00fdch l\u00e9k\u016f schv\u00e1len\u00fdch na z\u00e1klad\u011b n\u00e1hradn\u00edch dat neposkytlo \u017e\u00e1dn\u00e9 d\u016fkazy o zlep\u0161en\u00ed p\u0159e\u017eit\u00ed. Odhaduje se, \u017ee ve Spojen\u00fdch st\u00e1tech ka\u017edoro\u010dn\u011b zem\u0159e p\u0159ibli\u017en\u011b 128 000 lid\u00ed na vedlej\u0161\u00ed \u00fa\u010dinky spr\u00e1vn\u011b p\u0159edepsan\u00fdch l\u00e9k\u016f \u2013 v\u00edce ne\u017e na v\u0161echny neleg\u00e1ln\u00ed drogy dohromady. Podle d\u00e1nsk\u00e9ho l\u00e9ka\u0159e Petera G\u00f8tzscheho budou vedlej\u0161\u00ed \u00fa\u010dinky l\u00e9k\u016f do roku 2024 pat\u0159it mezi t\u0159i nej\u010dast\u011bj\u0161\u00ed p\u0159\u00ed\u010diny \u00famrt\u00ed na cel\u00e9m sv\u011bt\u011b.<\/span><\/p>\n

L\u00e9ka\u0159i jsou v temnot\u011b<\/span><\/strong><\/h3>\n

V\u011bt\u0161ina l\u00e9ka\u0159\u016f nech\u00e1pe, jak funguje proces schvalov\u00e1n\u00ed FDA. V pr\u016fzkumu JAMA z roku 2016 pouze \u0161est procent dot\u00e1zan\u00fdch l\u00e9ka\u0159\u016f spr\u00e1vn\u011b uvedlo, \u017ee schv\u00e1len\u00ed FDA nevy\u017eaduje klinicky v\u00fdznamn\u00fd p\u0159\u00ednos. V\u011bt\u0161ina se domn\u00edv\u00e1, \u017ee schv\u00e1len\u00ed automaticky znamen\u00e1 \u00fa\u010dinnost a bezpe\u010dnost.<\/span><\/p>\n

\u201eMnoho l\u00e9ka\u0159\u016f se spol\u00e9h\u00e1 na n\u00e1lepky, marketing nebo p\u0159edpoklady,\u201c \u0159\u00edk\u00e1 v\u00fdzkumn\u00edk z Harvardu Aaron Kesselheim. \u201eTo je v\u0161ak nebezpe\u010dn\u00fd omyl \u2013 s potenci\u00e1ln\u011b fat\u00e1ln\u00edmi n\u00e1sledky.\u201c<\/span><\/p>\n

Pro koho FDA pracuje?<\/span><\/strong><\/h3>\n

Z v\u00edce ne\u017e 100 rozhovor\u016f s odborn\u00edky, pacienty a b\u00fdval\u00fdmi zam\u011bstnanci FDA vy\u0161lo najevo: FDA ztratila ze z\u0159etele sv\u00e9 p\u016fvodn\u00ed posl\u00e1n\u00ed. Obzvl\u00e1\u0161t\u011b kritick\u00e9 je, \u017ee dv\u011b t\u0159etiny rozpo\u010dtu na schvalov\u00e1n\u00ed l\u00e9k\u016f poch\u00e1zej\u00ed z poplatk\u016f pr\u016fmyslu \u2013 struktur\u00e1ln\u00ed z\u00e1vislost, kter\u00e1 masivn\u011b podkop\u00e1v\u00e1 jej\u00ed nez\u00e1vislost.<\/span><\/p>\n

L\u00e9ka\u0159ka z Yale Reshma Ramachandran to shrnuje: \u201ePot\u0159ebujeme nez\u00e1vislou agenturu, kter\u00e1 bude hodnotit l\u00e9ky na z\u00e1klad\u011b vysoce kvalitn\u00edch v\u011bdeck\u00fdch d\u016fkaz\u016f. Jinak se vr\u00e1t\u00edme do \u00e9ry had\u00edho oleje a z\u00e1zra\u010dn\u00fdch pilulek.\u201c<\/span><\/p>\n

Z\u00e1v\u011br<\/span><\/strong><\/h3>\n

Pacienti v USA \u2013 a po cel\u00e9m sv\u011bt\u011b \u2013 \u010dasto u\u017e\u00edvaj\u00ed l\u00e9ky, kter\u00e9 nikdy nebyly dostate\u010dn\u011b testov\u00e1ny. FDA se prom\u011bnila z ochr\u00e1nce ve\u0159ejn\u00e9ho zdrav\u00ed v pasivn\u00edho raz\u00edtka pro pr\u016fmyslov\u00e9 z\u00e1jmy. Trp\u00ed l\u00e9ka\u0159i a pacienti \u2013 \u010dasto nev\u011bdomky. D\u016fv\u011bra v syst\u00e9m? Je st\u00e1le obt\u00ed\u017en\u011bj\u0161\u00ed ji ospravedlnit.<\/span><\/p>\n<\/div>\n<\/div>\n

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Zdroj<\/a><\/span><\/h3>\n

 <\/p>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

P\u0159esto\u017ee je FDA (FDA) americk\u00fdm \u00fa\u0159adem pro kontrolu l\u00e9\u010div, jeho rozhodnut\u00ed maj\u00ed velk\u00fd v\u00fdznam i…<\/p>\n","protected":false},"author":2,"featured_media":4295,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[7],"tags":[1088,1020,940,676],"_links":{"self":[{"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/posts\/82511"}],"collection":[{"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/comments?post=82511"}],"version-history":[{"count":0,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/posts\/82511\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/media\/4295"}],"wp:attachment":[{"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/media?parent=82511"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/categories?post=82511"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/tags?post=82511"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}