Komawa cikin watan Agusta na 2022, na rubuta wani yanki akan amincewar Paxlovid na Pfizer. Na yi magana game da yadda Fadar White House ta ba Pfizer biliyoyin daloli na masu biyan haraji kafin samar da tabbataccen binciken aminci ko inganci ga FDA.
A cikin amincewa da Paxlovid, Biden White House da FDA kuma da alama sun yi watsi da gangan daruruwan na gwaji na asibiti da aka gudanar a kan daruruwan dubban na marasa lafiya dalla-dalla da kafa aminci da inganci na IVM da kuma HCQ.
Kamar sauran abubuwa da yawa da Biden White House ke aiwatarwa, suna tilastawa ta hanyar ra'ayoyi da yawa, dabaru da wajibcin lafiyar jama'a wanda "kama” kamar su iya aiki, amma ba tare da buƙatun tabbataccen shaidar da aka samu ta hanyar kimiyya ba so aiki.
A saman wannan, Fadar White House ba ta da sha'awar koyo. Suna maimaita kuskuren da suka yi wajen kafa manufofin Amurka akai-akai. Gaggawa ko a'a; babu wani uzuri na yin watsi da hanyar kimiyya (ko amfani da rashin kyawun hanyoyin gwaji) don haka sanya Amurkawa cikin haɗari - musamman idan ana batun lafiyar jama'a.
Paxlovid ɗaya ne daga cikin dozin na misalai na lafiyar lafiyar jama'a (yawanci da yawa da za a lissafa anan) wanda gidan Biden White House ya rugujewa da ƙwararrun ƴan sanda a FDA. A game da Paxlovid, ba wai kawai an yi watsi da shaidar gazawar da gangan ba; An canza hanyoyin gwaji masu yiwuwa a tsakiyar gwaji don samun sakamako mai kyau lokacin da ya bayyana cewa sakamakon gwajin Paxlovid ba zai cika ainihin maƙasudin su ba. A gaskiya ma, Pfizer ya riga ya zaɓi dakatar da gwajin Paxlovid, amma sai ya canza tunaninsu bayan da FDA ta shiga ta Fadar White House.
Ko mafi muni: Its ba shine karo na farko da FDA ta yi ba kimiyyar da aka watsar a karkashin Biden (Na yi gargadin cewa wannan zai zama jigon maimaitawa a farkon 2021). Paxlovid ya gaza, amma Fadar White House ta riga ta biya Pfizer dala biliyan 5.3 a gaba. Maimakon yarda da gazawar da sharar almara, FDA ta shiga ciki kuma ba tare da nuna gaskiya ba, ta canza kafuwar gwajin gwaji na asibiti a tsakiyar gwaji don sa binciken Paxlovid ya yi kyau fiye da yadda suke. Daga nan sai Pfizer ya kammala gwajin, ya bayyana Paxlovid a matsayin nasara kuma fadar White House ta ninka jarin ta na dala biliyan 5.3, inda ta kashe jimillar dala biliyan 10.6 kan Paxlovid.
Wannan shawarar ta ɗabi'a da kimiyya ta amince da ma'aikatan farar hula masu biyan haraji, masu adalci da kansu waɗanda ke shelar hagu shine "jam'iyyar kimiyya"kuma yayi bikin cewa lokacin da aka zabi Biden,"manya sun dawo kan mulki. "
"Bin kimiyya” Jingle ɗinsu sun gaji, amma ba ainihin manufarsu ba.
Har ma mafi muni shine adadin ma'aikatan jinya, masu harhada magunguna da likitocin da suka shaida - kuma sun fahimci rashin da'a na kimiyya - amma sun kasance (kuma suna ci gaba da kasancewa) shiru, ba tare da fa'ida ba suna zabar bin shawarwarin asibiti daga 'yan siyasa, masu kula da asibitocin ofishin, labarai na yau da kullun ko kafofin watsa labarun. Ba shi yiwuwa a wuce gona da iri irin na tsoro, daidaito da kuma rashin aiki na waɗannan ƙwararrun wajen cin amanar rantsuwarsu don kare marasa lafiya.
A zahiri, Amurkawa har yanzu ba su da amsoshi da suka samar da Fadar White House, FDA ko wasu jami'an HHS akan:
1) Hankalin Fadar White House na siyan dala biliyan 10.6 na Paxlovid, kuma ba tare da tabbataccen shaidar aminci da inganci ba;
2) Yawancin allurai na Paxlovid da ba a yi amfani da su ba waɗanda za su ƙare a ƙarshe kuma za a jefar da su saboda rashin amfani, mafi ƙanƙanta cuta da ke sa cutar ta zama ba dole ba;
3) Bayyana ainihin abin da ya faru na "sake dawowa" cututtuka na Paxlovid (wanda zai zama da wuya ga likitocin kiwon lafiya na miyagun ƙwayoyi don ganowa saboda Fadar White House, Pfizer da FDA suna da kowane dalili a cikin duniya don yin rahotonsa, da "sakewa" ba wani jami'in ba ne [MedDRA] ba da rahoto mara kyau);
4) Ƙididdigar halin yanzu / tarihi da ƙididdiga da sauran sabbin abubuwan da suka faru na Paxlovid;
5) Cikakken bayanin sadarwa tare da Pfizer, Fadar White House da jami'an FDA tare da bayanin halal na kimiyya na dalilin da yasa aka canza sigogi masu mahimmanci na Paxlovid a tsakiyar gwaji kuma a maimakon fara sabon gwaji;
6) Masanin ilimin likitanci na hukuma, bayanin injiniya na "Paxlovid rebound";
7) Me yasa aka kwatanta gwajin Paxlovid da placebo kawai, kuma ba shi da IVM / HCQ / sauran makaman kwatance.
Labarin asali daga Agusta 2022 an sake bugawa a ƙasa.
Jim kadan bayan Shugaba Joe Biden touted murmurewa daga Covid a makon da ya gabata, ya sake gwada ingancin kwayar cutar, a cikin wani sake komawa shari'ar da ake dangantawa da maganin Paxlovid, wanda Biden yake sha.
Ba'amurke da yawa waɗanda suka ɗauki Pfizer's Paxlovid sakamakon kamuwa da cuta na Covid sun ɗanɗana abin da kowa ke kira "rebound Covid." Rebound Covid shine maimaita kwayar cutar da ke faruwa a cikin mutumin da ya riga ya murmure daga Covid, sau da yawa jim kadan bayan kammala Paxlovid.
Me ake nufi?
Masana kimiyya na asibiti suna ba da kowane nau'i na ka'idoji daban-daban, amma babu takamaiman bayani game da "sake dawowa" sabon abu na Paxlovid. Yana da wani asiri kuma ko da menene yake, ba zai iya zama mai kyau ba.
Me yasa Marasa Lafiya Masu Hatsari Mara Lafiya Sau Biyu?
Sake dawo da Covid bayan Paxlovid yana ɗaga mahimmancin lafiyar jama'a da lafiyar magunguna. A cewar hukumar NIH, kawai masu haɗari ne kawai ya kamata su sami Paxlovid, amma shan Paxlovid wani lokacin yana buɗe waɗancan majinyata masu haɗari guda ɗaya zuwa kamuwa da cuta ta Covid. A wasu lokuta, da dawo da Covid alamun sun fi muni, suna sanya majinyata masu haɗari iri ɗaya cikin haɗari mai tsanani.
Mutum ba ya buƙatar zama ƙwararren FDA don sanin cewa samun marasa lafiya masu haɗari suna rashin lafiya sau biyu ya fi sau ɗaya muni.
Me yasa Biden yake har yanzu bayar da shawarwari don amfanin Paxlovid, kwanan nan kamar makon da ya gabata? Domin fadar White House ba ta da zabin siyasa. Dole ne ko dai a) yarda gazawar ko b) watsi da lafiyar jama'a. Fadar White House ta yi wauta ta zaɓa biya Pfizer dala biliyan 10.6 don Paxlovid, bisa wani bincike na farko na "matukin jirgi" yana nuna kusan kashi 90 cikin XNUMX na inganci wanda daga baya ya narke cikin bincikensa ya gaza kuma Pfizer ya dakatar da shi da son rai kafin kammala shi.
Paxlovid ya gaza ƙarshen gwajin gwajin sa idan aka kwatanta da ƙungiyar placebo. Wataƙila Fadar White House ta Biden ba ta fahimci cewa binciken farko na matukin jirgi ba zai taɓa ƙarewa ba kuma "sakamakon" yana buƙatar tabbaci tare da gwajin asibiti na yau da kullun da lissafin masu canji kamar maye gurbi. Ko ba haka ba, Fadar White House ba ta jira har sai an kammala shari'ar ta yau da kullun kafin ta kashe dala biliyan 10.6 na masu biyan haraji.
Kashe Biliyoyin Akan Maganin Tambayoyi
Ayyukan Fadar White House ba su da uzuri. Ba wai kawai sun ƙi yarda cewa maganin ya gaza ba kuma suna da ba da wuri ba kuma ba daidai ba ya kashe dukiya mai yawa akan wani abu mara inganci kuma mai haɗari, amma sun ci gaba da inganta amfani da Paxlovid!
Maimakon kare marasa lafiya, Fadar White House tana zabar sadaukar da jin daɗin marasa lafiya da ke cikin haɗari.
Ainihin adadin dawowar Paxlovid yana da wuya a sani. Da farko, an gaya wa Amurkawa cewa "rare,” kasa da kashi 1. Sai aka ce mana 5.4 kashi, to, 10 kashi. A ranar 30 ga Yuli, 2022, wani manazarcin likita na CNN kuma Farfesa a Jami'ar George Washington ya bayyana cewa tare da sabon nau'in Covid shine "mai yiwuwa kashi 20-40 ko ma sama da haka.” Rahotanni masu zuwa daga kafofin watsa labarun yi da alama cewa babban kashi na mutanen da suka dauki Paxlovid sun sake komawa.
Shiru na CDC, FDA, NIH, da Dr. Fauci (wanda da kansa yana da shari'ar sake dawowa bayan ya ɗauki Paxlovid) yana da rauni, amma kuma ana iya faɗi.
Kama da alluran rigakafi da masu haɓakawa
Idan wannan ya zama sananne, saboda haka ne. Amurkawa sun ga ainihin abu iri ɗaya a baya game da illar rigakafin cutar ta Covid-19. Yayin da gwamnatin tarayya ta tsawatar da Amurkawa kan rashin samun alluran rigakafi da masu kara kuzari, sun kasance a lokaci guda shiru akan abubuwan da ba su dace ba kuma ko da m wajen danne su.
Ko da Paxlovid yana da tasiri, shin marasa lafiya suna buƙatar shi? A wannan gaba, tambaya iri ɗaya ta tafi ga rigakafin Covid-19 da masu haɓakawa. Mafi rinjayen bambance-bambancen a yau yawanci suna haifar da kamuwa da cuta mai sauƙi; yawancin mutane suna samun ƙarancin sanyi-kamar alamun sanyi daga cututtukan Covid ko allurar rigakafi ko a'a.
Yana kuma gaya cewa da yawa Amurkawa ba sa sha'awar masu haɓakawa. Idan da an nuna su suna aiki, mutane za su ɗauke su - amma ba su yi ba, don haka mutane ba sa. A cikin Amurka kawai, an tilasta wa gwamnati fitar da fiye da miliyan 82 allurai/ƙarfafa allurai, duk da haka Amurkawa ba sa mutuwa a ko'ina daga Covid-19. Ko cibiyoyin ilimi na hagu ba za su iya ɓoye ainihin shaidar cututtukan da ke fitowa daga asibitoci a cikin 'yan watannin da suka kwatanta rikodin lows a asibitin da ke da alaƙa da Covid-19 shigar da ICU.
Zurfafa Ramin Su
Duk da wannan duka, Fadar White House har yanzu tana neman siyan ƙarin rigakafi. A ranar 29 ga Yuli, Fadar White House ta kuduri aniyar siyan duka 171 miliyan alluran rigakafin Covid-19 don sabon maye gurbin omicron na Covid-19, duk da rashin shaidar gwaji na aminci ko inganci - misali, kamar yadda suka yi da Paxlovid!
Haɗin haɓaka masu haɓaka marasa iyaka na maganin alurar riga kafi wanda ya kasa hana kamuwa da cuta ko watsawa, tare da haɓaka Pfizer's Paxlovid duk da rashin ingancinsa da ilimin kimiyyar “sakewa” mai ban mamaki, ya sa na yi mamakin wani abu da na yi tunani akai na dogon lokaci, musamman a matsayin tsohon babban jami'in FDA: Shin akwai wani nau'in haɗin kai marar tsarki tsakanin FDA, Pfizer, da Biden White House?
Pfizer ciyarwa miliyoyin a cikin lobbying da gudunmawar yakin neman zabe. Its kofa mai juyawa tare da hukumomin lafiya na gwamnati ya shafi. Shin Fadar White House ta Biden za ta iya jefa lafiyar jama'ar Amurkawa cikin hadari da sunan siyasa? Ina addu'ar amsar ita ce a'a kuma ina fatan cewa nayi kuskure, watakila bacewar wani bangare na labarin, amma adadi mai karfi na nuni da zato na daidai ne.
Fadar White House da alama tana ɗokin ba da arziki ga Big Pharma don rashin tabbas, kuma mai yiwuwa mara lafiya ko mara amfani, kwayoyi. Ya kamata Amurkawa su yi la'akari da abin da suke ji daga fadar White House, jami'anta, da dukan Hukumomin haruffa na tarayya game da Paxlovid "magungunan al'ajabi."
Rubuta daga The tarayya
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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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