Iindleko zokuba "i-FDA ivunywe"
Amachiza omhlaza wesibeleko omtsha afika kwiimarike kunqabile ngenxa yokuba izifundo ezigunyazwe yi-FDA zibiza amawaka ezigidi zeedola. I-FDA idinga ukuba ezi zifundo zize zinike abantu ngamacandelo amabini. Elinye iqela lifumana iyeza elitsha livavanywa. Elinye iqela lifumana inkohliso engenamsebenzi, ebizwa ngokuba yi-placebo. Ukucinga ukuba isifundo senziwe ngendlela eyamkelekileyo, i-FDA iya kuvuma isilwanyana esitsha ukusetyenziswa kwezorhwebo, kuphela ukuba amadoda afumana iyeza elitsha aphulukise abo baphathwa nge-placebo ngolu hlobo oluchaziweyo ngaphandle kokutywala ngokweqile.
Ukufumana amawaka amavolontiya azimisele ukuthatha inxaxheba kulezi zifundo zilukhuni. Amadoda ayazi ukuba kukho ithuba lokufumana indawo engafanelekanga. Ngubani ofuna ukuthatha ithuba lokufumana ipilisi yeshukela xa ejongene nesifo esongela ubomi? Nangona kunjalo, emva kokusebenzisa zonke iindlela zokwelapha eziqhelekileyo ezikhoyo, ziyakhathazeka kwaye zibhalisele kwisifundo, enethemba lokuba nethamsanqa kwaye zifumane uMcCoy wangempela.
Ezi zifundo ziqhutyelwa iminyaka kuba zigqityiwe xa uninzi lwabathathi-nxaxheba befile ngenxa yomhlaza. Ukufumana inani elaneleyo labathathi-nxaxheba, iinkampani ezongamelayo eziququzelelayo nokuqhuba ezi zifundo zifuna ubudlelwane bekhontrakthi kunye namaziko angama-100 okanye ngaphezulu. Iindleko eziphezulu zezi zifundo zilula ukuqonda xa ucinga imfuneko yokugcina zonke izigulane ezahlukeneyo, kwiindawo ezininzi ezahlukeneyo, ngaphezu kwexesha elide.
Ukubonelela ngamanye amayeza e-FDA avunyelwe ukonyango lomhlaza wesifo seprotate oye wakwazi ukunqoba yonke le mingeni. Ukubonelela kunendlela ekhethekileyo yesenzo esisebenza ngokuqinisa umzimba wokuzivikela. UDendreon, umenzi, onelungelo lobunikazi kwinkqubo evuna amaseli omzimba ngaphandle kwegazi yi-plasmapheresis, inkqubo yeeyure ezintathu ezifana ne-dialysis.
Iiseli ezivunyiweyo zithathwa kwi-laboratory ekhethekileyo kwaye zixutywe nezinto ukuze zenze ulwaphulo olunxamnye nomhlaza. Iiseli ezifanayo ziphinde ziphinde zifakwe kwisiguli esifanayo.
Isibheno esisisiseko siphumo siphumo esiphantsi semiphumo emibi. Nangona kunjalo, unyango, olungathembeki kwi-chemotherapy, luguquguqulelo lokuba emva kokufunda okokuqala i-FDA iphoqelele inkampani ukuba iphinde iphinde iphinde iphinde iqinisekise ukuba unyango luhlala ludlulisa ubomi ngenxa yokungathembeki. Kwakhona, uphando lwesibini lubonise ukuba amadoda angaphathekiyo angama-30% amathuba okuba aphile iminyaka emithathu emva kokuba unyango lufaniswe namadoda athola indawo ye-placebo. Ekugqibeleni, i-FDA yavuma iziphumo zaza zavuma. Njengoko kunokucingelwa, ukulibaziseka, kungabi khankanya iindleko ezongezelelweyo zokuphinda isifundo, kwandisa kakhulu indleko yokuphuhliswa kweMpahla.
I-Jevtana, uhlobo oluphuculweyo lwe-chemotherapy, lenye i-arhente ukuba i-FDA ivunyiwe ngokusekelwe kwisifundo sokusinda ngokungapheliyo. Nangona kunjalo, esikhundleni se-placebo, i-Jevtana yayinganiswa ne-kymotherapy endala ebizwa ngokuba yi-Mitoxantrone eyanciphisa intlungu kodwa ayilondolozi ixesha lokuphila. Amadoda angamakhulu angama-755 ayesetyenziswe ngokukhawuleza kunyango kunye neJevtana okanye iMitoxantrone.
Ukusinda kwamadoda athola iYvtana kwakungama-30% angcono kunamadoda aphathwe ngeMitoxantrone.
Ibali lendlela uSanofi-Aventis azisa ngayo i-Jevtana, uhlobo olutsha lwe-chemotherapy, ukuthengiswa ngokumangalisa ngokugqithiseleyo ukuba inkampani yezoxuba, inomngcipheko omkhulu kuba bavavanya i-Jevtana kumadoda asele anqabile kwi-Taxotere. (I-Taxotere ithathwa njenge-"standard" ye-chemotherapy yomhlaza wesibeletho.) Le ndlela yathatha iingcali zoshishino ngenxa yamandulo, amadoda angamelana ne-Taxotere kulindeleke ukuba aphendule kakhulu nakwezinye i-chemotherapy. Nangona abantu be-naysayers, i-Jevtana ibonakaliswe ukuphucula ukusinda, kwinqanaba elingaxhatshali lezonyango.
Iindleko ze-antiticancer agents zangoku zilula ukuqonda xa ziqwalasela iminyaka yokufunda efuna inkcitho yamakhulu ezigidi zeedola. I-Jevtana ne-Provenge yimbali yempumelelo. Ngelishwa, xa sicinga ngeendleko eziphezulu zala mayeza kufuneka senze iindleko ezongezelelweyo ezininzi zezilwanyana eziye zavavanywa kwizilingo ezingenamsebenzi kodwa zahluleka ukubonisa ukuphuculwa kokusinda.
Ngoku ukuba i-Jevtana ne-Provenge baye baqinisekiswa ukuba bancede amadoda aphile ixesha elide, uphando oluthe gqolo luyaqhubeka ukuqinisekisa ukuba ezi zixhobo ezibalulekileyo ze-antiticancer zingasetyenziselwa ngendlela efanelekileyo kakhulu. Ngokukodwa, ukuphumelela kwabo kungaphakanyiswa ngakumbi ngokudibanisa namanye amayeza okanye ngeentlobo ezahlukeneyo zemitha.