{"id":80615,"date":"2025-06-07T00:15:40","date_gmt":"2025-06-06T22:15:40","guid":{"rendered":"https:\/\/www.infokuryr.cz\/n\/?p=80615"},"modified":"2025-06-06T18:24:24","modified_gmt":"2025-06-06T16:24:24","slug":"vybusne-vysetrovani-ukazuje-fda-schvaluje-stovky-leku-bez-dukazu-o-ucinnosti-a-svet-se-k-nim-pripojuje","status":"publish","type":"post","link":"https:\/\/www.infokuryr.cz\/n\/2025\/06\/07\/vybusne-vysetrovani-ukazuje-fda-schvaluje-stovky-leku-bez-dukazu-o-ucinnosti-a-svet-se-k-nim-pripojuje\/","title":{"rendered":"V\u00fdbu\u0161n\u00e9 vy\u0161et\u0159ov\u00e1n\u00ed ukazuje: FDA schvaluje stovky l\u00e9k\u016f bez d\u016fkazu o \u00fa\u010dinnosti \u2013 a sv\u011bt se k nim p\u0159ipojuje"},"content":{"rendered":"<div id=\"fb-root\"><\/div>\n<div class=\"elementor-element elementor-element-1fb4c2c elementor-widget elementor-widget-theme-post-content\" data-id=\"1fb4c2c\" data-element_type=\"widget\" data-widget_type=\"theme-post-content.default\">\n<div class=\"elementor-widget-container\">\n<h3><strong><span>Kritick\u00fd pohled na mezin\u00e1rodn\u00ed z\u00e1vislost na schv\u00e1len\u00ed ze strany USA<\/span><\/strong><\/h3>\n<p><span>Ned\u00e1vn\u00e1 zpr\u00e1va organizace\u00a0<\/span><em><a href=\"https:\/\/childrenshealthdefense.org\/defender\/fda-approved-hundreds-drugs-no-evidence-they-work\/\" target=\"_blank\" rel=\"noreferrer noopener\" data-type=\"link\" data-id=\"https:\/\/childrenshealthdefense.org\/defender\/fda-approved-hundreds-drugs-no-evidence-they-work\/\"><span>Children&#8217;s Health Defense<\/span><\/a><\/em><span>\u00a0odhaluje alarmuj\u00edc\u00ed vzorec: Mezi lety 2013 a 2022 schv\u00e1lil americk\u00fd \u00da\u0159ad pro kontrolu potravin a l\u00e9\u010div (FDA) stovky l\u00e9k\u016f bez dostate\u010dn\u00fdch d\u016fkaz\u016f o jejich \u00fa\u010dinnosti. Z celkem 429 nov\u00fdch l\u00e9k\u016f 73 procent nespl\u0148ovalo \u010dty\u0159i z\u00e1kladn\u00ed krit\u00e9ria \u00fa\u010dinnosti. Obzvl\u00e1\u0161t\u011b alarmuj\u00edc\u00ed je, \u017ee ze 123 zkouman\u00fdch l\u00e9k\u016f proti rakovin\u011b spl\u0148ovalo v\u0161echna krit\u00e9ria pouze 2,4 procenta \u2013 a 23 procent nespl\u0148ovalo ani jedno.<\/span><\/p>\n<p><span>Probl\u00e9m se net\u00fdk\u00e1 jen USA.<\/span><\/p>\n<h3><strong><span>Mezin\u00e1rodn\u00ed dopad: Pokud se FDA rozhodne, ostatn\u00ed budou n\u00e1sledovat<\/span><\/strong><\/h3>\n<p><span>FDA nen\u00ed jen n\u00e1rodn\u00ed agenturou, ale glob\u00e1ln\u00edm ukazatelem trendu. Jej\u00ed schv\u00e1len\u00ed stanovuj\u00ed standardy \u2013 a mnoho zem\u00ed je bu\u010f p\u0159\u00edmo p\u0159ij\u00edm\u00e1, nebo je pou\u017e\u00edv\u00e1 jako z\u00e1klad pro zrychlen\u00e9 postupy. To plat\u00ed zejm\u00e9na v nal\u00e9hav\u00fdch p\u0159\u00edpadech, u inovativn\u00edch terapi\u00ed nebo u politicky citliv\u00fdch l\u00e9k\u016f.<\/span><\/p>\n<p><span>Zem\u011b, kter\u00e9 pravideln\u011b dodr\u017euj\u00ed FDA nebo uzn\u00e1vaj\u00ed jeho rozhodnut\u00ed:<\/span><\/p>\n<ul>\n<li><span>Kanada (Health Canada)<\/span><\/li>\n<li><span>Austr\u00e1lie (TGA)<\/span><\/li>\n<li><span>Velk\u00e1 Brit\u00e1nie (MHRA)<\/span><\/li>\n<li><span>Zem\u011b EU prost\u0159ednictv\u00edm agentury EMA, zejm\u00e9na N\u011bmecko, Francie, Nizozemsko<\/span><\/li>\n<li><span>\u0160v\u00fdcarsko (Swissmedic)<\/span><\/li>\n<li><span>Mnoho zem\u00ed v Africe, Ji\u017en\u00ed Americe a Asii s vazbami na WHO nebo podporou Sv\u011btov\u00e9 banky<\/span><\/li>\n<\/ul>\n<p><span>Konkr\u00e9tn\u011b to znamen\u00e1, \u017ee l\u00e9ky schv\u00e1len\u00e9 v USA na z\u00e1klad\u011b slab\u00fdch dat se \u010dasto dost\u00e1vaj\u00ed na evropsk\u00e9 a mezin\u00e1rodn\u00ed trhy bez dal\u0161\u00edho testov\u00e1n\u00ed. Jedn\u00e1 se o regula\u010dn\u00ed dominov\u00fd efekt, kter\u00fd je spu\u0161t\u011bn t\u00edm, \u017ee agentura je st\u00e1le v\u00edce pod politick\u00fdm, ekonomick\u00fdm a \u010dasov\u00fdm tlakem.<\/span><\/p>\n<h3><strong><span>Syst\u00e9mov\u00e1 chyba<\/span><\/strong><\/h3>\n<p><span>FDA se v mnoha rozhodnut\u00edch o schv\u00e1len\u00ed spol\u00e9h\u00e1 na tzv. n\u00e1hradn\u00ed c\u00edlov\u00e9 parametry nebo pr\u016fb\u011b\u017en\u00e9 v\u00fdsledky \u2013 jako jsou biochemick\u00e9 markery nebo zmen\u0161en\u00ed n\u00e1doru \u2013 sp\u00ed\u0161e ne\u017e na konkr\u00e9tn\u00ed data, jako je doba p\u0159e\u017eit\u00ed nebo skute\u010dn\u00e9 vyl\u00e9\u010den\u00ed. V d\u016fsledku toho jsou farmaceutick\u00e9 trhy pln\u00e9 l\u00e9k\u016f, jejich\u017e p\u0159\u00ednosy jsou sporn\u00e9, ale jejich\u017e rizika jsou re\u00e1ln\u00e1.<\/span><\/p>\n<h3><strong><span>Rostouc\u00ed tlak, klesaj\u00edc\u00ed p\u00e9\u010de<\/span><\/strong><\/h3>\n<p><span>Farmaceutick\u00e9 spole\u010dnosti maj\u00ed z\u00e1jem na rychl\u00fdch postupech \u2013 a politici jim hraj\u00ed vst\u0159\u00edc. Vl\u00e1dy cht\u011bj\u00ed demonstrovat svou inovativn\u00ed s\u00edlu, m\u00e9dia prosazuj\u00ed rychl\u00e1 \u0159e\u0161en\u00ed zdravotn\u00edch kriz\u00ed a \u00fa\u0159ady jsou pod tlakem, aby jednaly. Ochrana pacient\u016f \u010dasto upad\u00e1 stranou.<\/span><\/p>\n<h3><strong><span>Z\u00e1v\u011br<\/span><\/strong><\/h3>\n<p><span>Anal\u00fdza organizace\u00a0<\/span><em><span>Children&#8217;s Health Defense<\/span><\/em><span>\u00a0by m\u011bla slou\u017eit jako varov\u00e1n\u00ed pro v\u0161echny zem\u011b, kter\u00e9 se spol\u00e9haj\u00ed na FDA. Je nal\u00e9hav\u011b nutn\u00e9 se vr\u00e1tit k nez\u00e1visl\u00e9mu testov\u00e1n\u00ed l\u00e9k\u016f zalo\u017een\u00e9mu na d\u016fkazech \u2013 a to jak na n\u00e1rodn\u00ed, tak i na mezin\u00e1rodn\u00ed \u00farovni. Ti, kdo slep\u011b n\u00e1sleduj\u00ed americk\u00fd regula\u010dn\u00ed org\u00e1n, riskuj\u00ed, \u017ee ve sv\u00fdch vlastn\u00edch syst\u00e9mech zdravotn\u00ed p\u00e9\u010de zavedou ne\u00fa\u010dinn\u00e9 nebo dokonce nebezpe\u010dn\u00e9 l\u00e9ky.<\/span><\/p>\n<\/div>\n<\/div>\n<div class=\"elementor-element elementor-element-8c57238 quelle dc-has-condition dc-condition-empty elementor-widget elementor-widget-heading\" data-id=\"8c57238\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n<div class=\"elementor-widget-container\">\n<h3 class=\"elementor-heading-title elementor-size-default\"><span style=\"font-size: 10pt;\"><a href=\"https:\/\/childrenshealthdefense.org\/defender\/fda-approved-hundreds-drugs-no-evidence-they-work\/\" target=\"_blank\" rel=\"nofollow noopener\">Zdroj<\/a><\/span><\/h3>\n<p>&nbsp;<\/p>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Kritick\u00fd pohled na mezin\u00e1rodn\u00ed z\u00e1vislost na schv\u00e1len\u00ed ze strany USA Ned\u00e1vn\u00e1 zpr\u00e1va organizace\u00a0Children&#8217;s Health Defense\u00a0odhaluje&#8230;<\/p>\n","protected":false},"author":2,"featured_media":80616,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[7],"tags":[1088,1020,7310,37],"_links":{"self":[{"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/posts\/80615"}],"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=80615"}],"version-history":[{"count":1,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/posts\/80615\/revisions"}],"predecessor-version":[{"id":80617,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/posts\/80615\/revisions\/80617"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/media\/80616"}],"wp:attachment":[{"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/media?parent=80615"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/categories?post=80615"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/tags?post=80615"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}