20 luglio 2018

Vaccino GARDASIL: Una decisione storica

Il Tribunale federale del Canada decide di divulgare dati di test clinici a ricercatori statunitensi
CBC News (1), insieme al British Medical Journal (2) riportano che il professor Peter Doshi ha vinto un'importante vittoria legale sulle società farmaceutiche che cercano di nascondere i dati delle sperimentazioni cliniche al pubblico, affermando che si tratta di "accordi riservati" per 5 prodotti farmaceutici.
Doshi ha fatto causa a Health Canada affinché fornisse i dati sulle sperimentazioni cliniche presentate dai produttori di vaccini contro l'HPV, Gardasil 9 e Cervarix, nonché farmaci antivirali contro l'influenza come Tamiflu e Relenza.
Un giudice della Corte Federale del Canada ha ordinato ad Health Canada (il Ministero della Sanità) affinché divulgasse i dati degli studi clinici sui prodotti farmaceutici sopra elencati, minando in tal modo i tentativi del governo canadese di mantenere tali informazioni riservate. Come spesso succede, questa storica decisione canadese è stata completamente censurata nei media "mainstream" sponsorizzati da compagnie americane.

Tutto questo fa parte di una brillante strategia legale del Dr. Doshi e dei suoi avvocati, in quanto hanno avuto poche o nessuna possibilità di ottenere questi dati di studi clinici da un tribunale negli Stati Uniti, dove le compagnie farmaceutiche godono dell'immunità legale contro la maggior parte dei procedimenti giudiziari. L'importanza di ricevere questi dati, specialmente sul vaccino Gardasil di Merck, non può essere sottovalutata.

L'intera procedura di approvazione medica per l'introduzione del vaccino per il Papillomavirus (HPV) nel mercato statunitense è piena di scandali e insabbiamenti che hanno portato problemi di salute e decessi di molte giovani, specialmente giovani donne di età compresa tra i 12 e i 26 anni, molte delle quali non possono più avere figli, in seguito alla somministrazione del vaccino che le ha rese sterili.

"Spero che il mio caso stabilisca un precedente e consenta anche a ricercatori, medici e pubblico di accedere facilmente ai dati degli studi clinici", ha affermato il dott. Doshi in una e-mail inviata a CBC News.
"I legislatori non dovrebbero avere il monopolio sulla valutazione dei rischi e dei benefici dei farmaci. Né dovrebbero impedire agli altri di fare lo stesso attraverso accordi di riservatezza".
La decisione del Giudice della Corte Federale del Canada, Sébastien Grammond, che ha descritto la posizione di Health Canada come "irragionevole", è stata accolta da altri esperti legali in Canada, secondo CBC News.

La Corte ha chiarito che era nell'interesse pubblico avere accesso a tali informazioni affinché i ricercatori indipendenti potessero monitorarle. Questo accesso alle informazioni pertanto supera di gran lunga qualsiasi interesse a proteggere gli interessi commerciali", ha affermato Matthew Herder, direttore del Dalhousie Health Law Institute, Università di Halifax.

Herder, che ha studiato il caso da vicino, ha detto che spera che questa decisione coraggiosa porterebbe i ricercatori, anche al di fuori del Canada, a iniziare a chiedere dati su altri farmaci attualmente sul mercato.

Il dott. Peter Doshi ha criticato pubblicamente le compagnie farmaceutiche e le politiche governative che fuorviano il pubblico in merito alla sicurezza dei farmaci nascondendo i dati degli studi clinici disponibili su medicinali disponibili al pubblico e ai ricercatori indipendenti.
Il dott. Doshi è riuscito a spingere le più grandi aziende farmaceutiche del mondo ad aprire i loro file in modo che i vantaggi e i potenziali svantaggi di questi farmaci che il pubblico impiega ogni giorno, siano finalmente compresi meglio.
Con un gruppo di ricercatori e attivisti provenienti da tutto il mondo, il dott. Doshi sta cercando di portare alla luce i dati delle sperimentazioni cliniche, si tratta di studi complessi che durano per anni e che spesso coinvolgono migliaia di pazienti in molti paesi, per rendere finalmente questi dati pubblici.

Nel sistema attuale, dicono gli attivisti, ci sono solo pochi dettagli di studi clinici pubblicati su riviste mediche, spesso anche da autori con legami finanziari con le società per le quali scrivono gli articoli. Sembra ovvio che questi dati sono insufficienti e fuorvianti.

Questa decisione in Canada rappresenta una grande vittoria per il Dott. Doshi e dovrebbe portare a una maggiore trasparenza negli studi clinici sui farmaci e potenzialmente consentire il perseguimento di società farmaceutiche non etiche che commercializzando farmaci. prodotti pericolosi come il vaccino antinfluenzale annuale e i vaccini HPV.

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