Komawa a farkon 2000s, FDA ta ƙaddamar da Kwamitin Gudanar da Tsaro na Farko (SFSC). An fara ne don magance matsalolin tsaro na magungunan da ake sayar da su wanda ke da mahimmanci ga Amurkawa. A yau, acronym har yanzu ana samunsa a ko'ina duk takardun FDA, amma wadancan hanyoyin daina aiki.
It ya bayyana Hukumar Kula da Hadarin Magunguna (DRMB) ta maye gurbinsu. DRMB ba shi da shafin yanar gizon da ke fuskantar jama'a, amma shi ya bayyana cewa DRMB shine kawai SFSC da aka sakewa.
da FDA:
"DrMB kwamitin gudanarwa ne na CDER wanda ke da alhakin manyan manufofi guda uku: (1) sauƙaƙewa da daidaita yanke shawara game da manyan al'amurran aminci na samfur, (2) samar da tabbataccen jagora mai dacewa wanda ke ba da damar amsa da ta dace ga manyan batutuwan aminci, da (3) cikin tsarin sadar da yanke shawara da sakamakon sakamako a cikin Cibiyar da sauran masu ruwa da tsaki kamar yadda ya dace.
Hukumar Kula da Tsaron Magunguna ya Dr. Patrizia Cavazzoni, shugabar Cibiyar Nazarin Magunguna da Magunguna ta FDA (CDER). Cavazzoni ya yi murabus ba zato ba tsammani sa'o'i kadan kafin rantsar da Donald Trump a ranar 20 ga Janairu, 2025.
Kodayake ba a bayyana ma'aikatan DRMB ko minti na taro ba, FDA Muhimmancin Tsaron Magunguna rahotannin shekara-shekara ne. Ɗaya daga cikin abubuwan da suka fi dacewa da suka ɓace daga waɗannan rahotanni a cikin shekaru goma da suka gabata ko makamancin haka shine duk wani ambaton tallan tallan tallan-lakabin-lakabin haɓakar hormone (wanda kuma ake kira GnRH masu daidaitawa ko masu hana balaga) da / ko hormones na jima'i a cikin yara, da sunan "canjin jinsi."
FDA ta fitar da rahoto na shekara-shekara kan abin da ta ɗauka a matsayin "Matsalolin Tsaron Magunguna" ga Hukumar
Ba abin mamaki ba ne da gaske cewa Cavazzoni - likitan hauka kuma tsohon ma'aikacin Big Pharma na kusan shekaru ashirin kafin ya shiga FDA - zai rufe ido ga amincin miyagun ƙwayoyi dangane da siyasa. A lokacin jagorancinta, Cavazzoni ya kafa doka yanke shawara game da tsarin siyasa da ci gaban wasu manufofin Biden/Harris White House gami da da yawa marasa inganci kuma masu haɗari samfuran cutar Alzheimer, har da Neman gwajin dabbar dabba mai muguwar dabi'a a maimakon sabbin hanyoyin da ba su da dabba.
A matsayinta na shugabar DRMB, Cavazzoni yakamata ya tantance abin da ke da fifiko. Cavazzoni ya ƙaddara cewa dubun-dubatar balaguro na hana transgender miyagun ƙwayoyi miyagun ƙwayoyi - ciki har da mace-mace, asibiti, da nakasu na dindindin - kawai ba fifikon "Hukumar Kula da Hadarin Magunguna".
Memba daya tilo da aka bayyana a bainar jama'a na DSMB shine Dokta Patrizia Cavazzoni, Daraktan CDER. Cavazzoni ta shafe dukan aikinta kafin FDA ta yi aiki ga Big Pharma. Duk da cewa"M"Da kuma"Faɗakarwa"kokari a"kiyaye takardar sayan magani na kasa[s]” ta yi watsi da kusan abubuwan da ba su dace ba 70,000 daga masu hana balaga a cikin kowace ta. rahotanni na shekara-shekara.
A cikin shekaru ashirin da suka gabata, kusan rahotanni 70,000 na cutarwa daga magungunan hana balaga da aka ƙaddamar da su zuwa Database's Adverse Event Reporting Database (AERS). Amma duk da haka rahoton FDA "Hukumar Kula da Hadarin Magunguna" bai taɓa ambata ɗayan waɗannan ƙaddamarwa ba.
Bugu da ƙari ga AERS, bayanan da aka buga sun nuna cewa ana danganta hormones na jima'i da masu hana balaga ya karu sosai (nnki 7) haɗarin bugun jini, bugun zuciya, da gudan jini tare da ƙarin nazarin kuma yana nunawa mugayen abubuwan da ke haifar da barazanar rayuwa da kuma sauran m, physiologically m sakamako.
A wani bayanin kula, da alama FDA DRMB tayi watsi da Covid mRNA da sauran batutuwan aminci na zamanin Covid kuma.
Mutum zai yi tunanin haka kowane irin na mummunan al'amari wani abu ne da FDA za ta ji cewa wajibi ne ta gargadi masu biyan haraji na Amurka, amma saboda dalili ɗaya ko wani, ba haka ba.
Masu hana balaga wani lamari ne na musamman don tattaunawa mai aminci, kamar yadda ake amfani da su wajen toshe alamar halitta cigaban ilimin halitta na balaga a cikin yara masu lafiya da matasa. Kafin a yi amfani da su don canza jinsi, ana ba da waɗannan magungunan don cututtukan cututtukan endocrine masu barazanar rai ko ciwon daji a cikin tsofaffi ko tsofaffi. Kwatankwacin farashi na kit ɗaya (samar da wata ɗaya), leuprolide (Lupron) yana kashe ko'ina daga sama da $12,000 zuwa sama da 14,000 kowane wata shida. tare da coupon online. Bugu da ƙari, a ƙarƙashin Gwamnatin Biden, masu biyan haraji za su rufe masu hana balaga don maganin transgender:
Masu Kashe Balaga da Hormones Sex Sex
Gudanar da magungunan roba, jima'i da ba su dace ba da / ko abin da ake kira masu hana balaga balagagge ba su ne hormones - ba duk magungunan ku na yau da kullum ba. Hormones suna da ƙarfi musamman, nau'ikan nau'ikan nau'ikan sigina na sigina waɗanda aka yi ta pituitary na baya (A/K/A “gland glandHormones (na halitta ko na roba) don haka masu karɓar jiki suna ganin su azaman umarni mai ƙarfi musamman.
A gefe guda kuma aikin mutum na halitta na halitta da aikin hormonal. Akwai ~Tiriliyan 100 da ke da kwayoyin halitta tare da haɗin "XX" (mace) ko "XY" (namiji) wanda ke nuna jinsin mace ko namiji, bi da bi. Hormones da pituitary mutum ya fito da shi yana haɓaka ci gaban ilimin lissafi na al'ada; Hormones da ba su dace da jima'i ba suna katse wannan aikin nazarin halittu. Wannan hargitsi tsakanin lafiyar lafiyar mutum da sinadarai na waje yana nufin cewa kowane irin illar da zai iya tasowa yayin da ilimin halittar mutum ya shiga rudani.
Misalin injuna wanda aka sauƙaƙa sosai zai kasance ƙoƙarin fitar da motar ku a duk faɗin Amurka ta madadin/lokaci guda tare da latsa gas da fedal ɗin birki, yayin da kullun ke jujjuya zuwa injin bazuwar. Ba za ku samu ko'ina ba da kuma lalata motar.
Siyasa Yana Faɗa Yadda FDA Ta Gargaɗi Amurkawa Game da Tsaron Magunguna
Kodayake FDA tana da gargadi nau'ikan nau'ikan toshe balaga na iya haifarwa barazanar rai kumburin kwakwalwa, ciwon kai, amai, tarin rikice-rikice na gani (ciki har da makanta), da/ko masu kama da ƙari a cikin kwakwalwa, ya yi zurfi sosai a cikin sanarwa da wallafe-wallafen inda ba za a iya samun su cikin sauƙi ba; bai yi sanarwar jama'a ba ga masana harhada magunguna, likitoci, ko jama'ar Amurka.
A gefe guda, FDA ta yi fice sosai kuma ta yi gargaɗi game da hatsarori na amfani da lakabin kwayoyi kamar su. hydroxychloroquine da kuma ivermectin, babu wanda ya samu ko'ina kusa faɗin ko abubuwan da suka faru na aminci idan aka kwatanta da na transgender pharmacotherapy.
Lokacin da FDA ta zaɓi yin magana game da hydroxychloroquine don Covid, ta fara salvo na tallan kafofin watsa labarun da ƙari. mahara sadaukarwa shafukan yanar gizo da kuma videos gaba da shi. Hakan ya biyo baya kawai 331 rahotanni masu ban tsoro sama da watanni shida - yawancin su an yi amfani da su a fili tare da kuskuren kuskure ko rashin mahimmancin mahimman allurai da/ko bayanan lokaci.
Har ila yau FDA ta yi tallan nasarar da ta samu wajen gargadin masu amfani da intanet, wanda ya sa gidan yanar gizonsa ya zama na farko binciken intanet wanda ke kaiwa ga shafukan yanar gizon FDA, kuma "a saman batutuwa masu tasowa a kan dandamali na kafofin watsa labarun. "
A cikin rahotonta na 2020 don Mahimman Tsaron Magunguna rahoto (shafi na 42), shugabancin FDA CDER ya yi kururuwa game da yadda ya sami damar haɓaka binciken hydroxychloroquine a matsayin lamba ɗaya na Google zuwa shafin yanar gizon FDA.gov.
A bayyane yake, FDA ta sani daidai yadda za a sanar da Amurkawa game da muhimman al'amuran kare lafiyar ƙwayoyi…if yana so.
Tare da rantsar da Donald Trump a matsayin shugaban kasa, tsoffin FDA-ers kamar ni na sa ido don ganin ingantaccen gyaran FDA, nuna gaskiya, da kuma ɗaukar matakan kare lafiyar miyagun ƙwayoyi ba na siyasa ba. Umurnin zartarwa na Trump zuwa Kare Yara Daga Sinadari Da Fida mataki ne a kan madaidaiciyar hanya, amma shugabancin FDA yakamata ya damu da hakan da kansa, kuma shekaru da suka wuce.
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Dokta David Gortler masanin ilimin harhada magunguna ne, likitan harhada magunguna, masanin kimiyyar bincike kuma tsohon memba na Babban Jami'in Gudanarwa na FDA wanda ya zama babban mai ba da shawara ga Kwamishinan FDA akan al'amuran: Al'amuran ka'idoji na FDA, amincin magunguna da manufofin kimiyya na FDA. Shi tsohon jami'ar Yale ne da kuma jami'ar Georgetown didactic farfesa a fannin harhada magunguna da fasahar kere-kere, tare da sama da shekaru goma na koyar da ilimin kimiyya da bincike na benci, a zaman wani bangare na kwarewarsa ta kusan shekaru ashirin a ci gaban muggan kwayoyi. Shi babban ɗan'uwa ne a fannin kiwon lafiya da manufofin FDA a Gidauniyar Heritage a Washington DC da 2023 Brownstone Fellow.
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