si faci un studiu care sa dea bine la medici, parinti si in presa, apoi iesi la shopping de medici si jurnalisti si gata , ai campania si piata pentru vaccin. OK .. dupa aceea este necesar sa fabrici pastile de nesimtire si surzenie, sa ameninti, orice numai sa nu ajugi sa ai pe piata informatii contrare povestii oficiale.
Am mai spus pe ici pe colo despre intrebarile puse de oamenii de stiinta germani, dar nu am avut timp sa traduc documentul lor. Il postez in engleza si voi reveni sa-l traduc. Mai ales ca, din cate am aflat pana acum, inca nu exista acces la datele studiilor si la modul in care producatorii au obtinut cifrele faimoase necesare in campania de prostire.
Oamenii de stiinta din Germania cer o reanalizare a vaccinarii HPV si incetarea informarii inselatoare [a publicului]
Incepand cu toamna anului 2006, fetele adolescente din Germania pot fivaccinate impotriva virusului HPV (human papilloma virus). De atunci incoace s-a discutat intens despre posibilele efecte adverse si despre costurile vaccinului, dar si despre informatiile inselatoare transmise publicului. Intrebarea despre cat de eficient este, cu adevarat, acest vaccin nu prea se pune. Si totusi este crucial acest aspect de eficacitate – de exemplu, nu a fost niciodata suficient evaluat gradul pana la care acest vaccin micsoreaza sansele de a avea cancer de col uterin si exact aceasta informatie este informatia inselatoare.
STIKO a recomandat vaccinul inainte ca studiile relevante sa fie publicate. In martie 2007 “Ständige Impfkommission” (STIKO) [Standing Vaccination Committee] de la Robert Koch-Institute a recomandat vaccinul HPV pentru toate fetele cu varsta intre 12 si 17 ani pentru a scadea incidenta de cancer de col uterin. DAR, la momentul cand s-a facut aceasta recomandare, rezultatele studiului decisiv INCA NU ERAU PUBLICATE.
Abia in Mai 2007 au fost publicate in The New England Journal of Medicine (NEJM) cele mai importante studii despre Gardasil, respectiv studiile FUTURE I si FUTURE II.
Mesajul central al unui editorial publicat un an mai tarziu in acelasi jurnal era: „Vestea proasta este ca efectul total al vaccinului in cazul cancerului de col uterin ramane necunoscut” (Haug 2008)1. Cel mai important studiu despre cel de-al doilea vaccin, Cervarix, a fost publicat in iunie 2007. [..]
Ce spun studiile si celelalte documente despre eficacitatea vaccinurilor anti HPV? Cancerul de col este asociat cu infectia cu HPV. Din aproximativ cele 100 de tulpini cunoscute, cel putin 13 pot declansa cancerul cervical. Se presupune ca tulpinile 16 si 18, tintite de aceste vaccinuri, sunt responsabile pentru 70% din toate cazurile de cancer de col.
Oricum, in loc sa masoare efectul acestor vaccinuri impotriva cancerului de col, studiile au examinat incidenta leziunilor [intraepiteliale] de col ( potential precursoare ale cancerului cervical) la femeile cu varste cuprinse intre 15 si 26 de ani.
Vaccinul a produs, intr-adevar, o scadere cu 98% (2) a incidentei stadiilor precanceroase asociate cu HPV 16 sau 18 la femeile care nu fusesera infectate cu aceste 2 tulpini. Acest rezultat a condus la mult optimism si a fost proclamat peste tot ca 70% din cazurile de cancer de col asociate cu HPV 16 si 18 pot fi prevenite aproape complet, ajungandu-se astfel la o scadere aproape completa a cazurilor de cancer de col -din cele 70% declarate ca fiind cauzate de HPV. Dar aceasta presupunere nu a fost niciodata confirmata prin studii stiintifice.
In analizele ce includ toate femeile inrolate [in studiul clinic], FUTURE I a aratat o scadere de 7.8% (3) a incidentei tuturor leziunilor cervicale de grad inalt ( cifra a fost luata de la EMEA 2008 ), iar FUTURE II a aratat o scadere de 17% (4). Aceste evaluari nu au fost considerate de STIKO. Referitor la cel de-al doilea vaccin, Cervarix, STIKO si-a bazat recomandarile exclusiv pe datele despre preventia infectiilor persistente. Date legate de eficacitatea vaccinului Cervarix impotriva stadiilor precanceroase sau a cancerului [de col] nu sunt inca disponibile.
Eficacitatea Gardasil, ce a fost caracterizata ca fiind „modesta”, a fost partial explicata de faptul ca o parte din femeile examinate erau deja infectate cu HPV 16 sau 18. Este bine stiut ca vaccinul nu functioneaza daca o femeie este deja infectata. Asa ca s-a recomandat ca femeile sa fie vaccinate inainte de a fi infectate cu HPV, de exemplu inainte de a deveni active sexual. STIKO, in recomandarile sale, a stabilit varsta ca fiind intre 12 si 17 ani. Datele referitoare la eficacitatea impotriva stadiilor incipiente de cancer de col se refera numai la femeile cu varsta intre 15 si 17 ani si nu la cele intre 12 si 14 ani.
Pentru a acoperi lipsa acestor date, studiile FUTURE au condus analize statistice ce au inclus numai fete si femei ce erau neinfectate cu HPV 16 si 18 la inceputul studiului. Acest grup s-a presupus ca este aproximativ ca cel al fetelor de 12 ani. Oricum, a ramas neclar cum afecteaza Gardasil numarul total de leziuni cervicale de grad inalt in acest grup. Singurele date disponibile vin dintr-un studiu de follow-up timp de 2 ani al studiilor FUTURE publicate de FDA in 2006 , iar acest studiu arata o eficacitate de 16.9% (5). Studiul FUTURE II arata o eficacitate estimata de 27% (6). EMEA ofera o estimare de 37.9% (7) pentru 2006 si 46.1% (8) pentru 2007 in cazul unor populatii variate. Oricum, pentru a ajunge la aceasta cifra de 46.1%, aproximativ jumatate din femeile inrolate [in studiul clinic] au fost excluse post hoc.
Cand le-au fost cerute date suplimentare, Sanofi-Pasteur MSD Germania a replicat: „Cifrele si tabelele nepublicate sunt disponibile NUMAI colegilor care sunt direct implicati in evaluarea rezultatelor la sediul din SUA. Noi nu avem aceste date si nici nu le vom cere/primi”.
Recomandarea STIKO pentru vaccinarea HPV trebuie reanalizata acum. Recomandarile facute de STIKO in martie 2007 nu au fost bazate pe date clare despre eficacitate [vaccinului]. In schimb, STIKO mentioneaza ca „imunitatea pe viata” a fost in 92.5% [din cazuri] (9), bazandu-si aceasta afirmatie probabil pe propriile lor extrapolari. Nu s-a oferit nici o explicatie despre cum s-a obtinut aceasta cifra si nu au existat – nu exista – date despre imunitatea „pe viata”. Nici un studiu nu a indicat o eficacitate de o asemenea magnitudine.
Recomandarile STIKO trebuie re-evaluate imediat. STIKO ar trebui sa ia in considerare rezultatele studiilor mai recente si sa ceara producatorului accesul la datele lipsa, iar aceste date trebuie incluse intr-o noua evaluare. Aceasta evaluare trebuie sa indice clar si precis ce eficacitate asteapta STIKO de la vaccin si pe ce presupuneri si date reale se bazeaza.
Adolescentele si femeile trebuie sa fie informate in mod adecvat. Rezultatele studiilor contrazic in mod clar multe dintre afirmatiile optimiste [facute pana cum]. Adolescentele si femeile au dreptul sa fie informate corect. Suntem complet impotriva modului in care se genereaza frica legata de riscul cancerului de col si sentimentele de vinovatie prin diseminarea de informatii incorecte. Cerem ca discrepantele din datele existente sa fie discutate deschis. Afirmatii de genul ca un vaccin reduce riscul cancerului de col cu 70% sau chiar 98% pur si simplu nu ar trebui sa fie facute acum. In locul acestor afirmatii, ar trebui folosite informatii care sunt dovedite de cercetari corecte si care dau tuturor celor implicati oportunitatea de a alege in cunostinta de cauza.
Prof. Martina Dören, Dr. Ansgar Gerhardus, Prof. Ferdinand M. Gerlach, Prof. Claudia Hornberg, Prof. Michael M. Kochen, Prof. Petra Kolip, Prof. Wolf-Dieter Ludwig,,Prof. Ingrid Mühlhauser, Prof. Oliver Razum, Prof. Rolf Rosenbrock, Corinna Schach, Prof. Norbert Schmacke, Prof. Jürgen Windeler
Contact: Dr. Ansgar Gerhardus, Universität Bielefeld, ansgar.gerhardus@uni-bielefeld.de
Scientists in Germany call for a reassessment of the HPV vaccination
and an end to misleading information
As of autumn 2006, adolescent girls and women in Germany can be vaccinated against human
papilloma virus (HPV). Ever since then there have been intense discussions about possible
side effects and the costs of the vaccines, as well as the partly misleading promotional
information which is given out to the public. The question of how effective the vaccines really
are is hardly ever asked. Yet this crucial issue of efficacy – i.e., to what degree the vaccine
actually lowers the rate of new cervical cancer cases – has not been sufficiently evaluated, and
is the object of misleading information.
STIKO made its recommendations before the relevant studies were published
In March 2007 the “Ständige Impfkommission” (STIKO) [Standing Vaccination Committee]
of the Robert Koch-Institute recommended the HPV vaccine for all girls aged 12-17 years to
decrease the burden of disease due to cervical cancer. However, at the time the
recommendation was made, the results of the decisive studies had not yet been published.
It was not until May 2007 that the most important studies on the Gardasil® vaccine, FUTURE
I and FUTURE II, were published in The New England Journal of Medicine (NEJM). The
central message of an editorial published in this journal more than one year later was: “The
bad news is that the overall effect of the vaccines on cervical cancer remains unknown” (Haug
2008)1. The most important study on the second vaccine, Cervarix®, was published in June
2007. Cervarix® has not yet been approved in the USA.
What do studies and other documents say about the efficacy of the HPV vaccines?
Cervical cancer is closely associated with HPV infection. Of the approximately 100 known
strains of HPV, at least 13 can trigger cervical cancer. Strains 16 and 18, which are the target
of these two vaccines, are assumed to be responsible for 70% of all cervical cancer cases.
However, rather than assessing the effect of the vaccine against cervical cancer, the studies
examined the incidence of high-grade cervical lesions (a potential precursor of cervical
cancer) in 15-26 year-old women.
The vaccine did achieve a 98%2 decrease in the precancerous stages associated with HPV 16
or 18 in women who had not yet been infected with these two strains. This gave rise to much
optimism, and it was widely proclaimed that the 70% of cervical cancer cases associated with
HPV strains 16 and 18 could be almost completely prevented (thus achieving a decline in all
cervical cancer cases of almost 70%). This assumption, however, has so far not been
confirmed by studies.
In analyses which included all women enrolled, FUTURE I found a decline of 7.8%3 in the
incidence of all high-grade cervical lesions (number extracted from EMEA [European
Medicines Agency] 2008), and FUTURE II a decrease of 17%.4 These evaluations have not
yet been considered by STIKO. Regarding the second vaccine, Cervarix®, STIKO based its
recommendations exclusively on data on the prevention of persistent infections. Data
regarding the efficacy of Cervarix® against precancerous stages or cancer were not yet
available.
The efficacy of Gardasil®, which has been described as “modest”, was partially explained by
the fact that some of the women examined had already been infected with HPV 16 or 18. It is
well known that the vaccine does not work once women have been infected. Hence it Scientists in Germany call for a reassessment of the HPV vaccination
and an end to misleading information
As of autumn 2006, adolescent girls and women in Germany can be vaccinated against human
papilloma virus (HPV). Ever since then there have been intense discussions about possible
side effects and the costs of the vaccines, as well as the partly misleading promotional
information which is given out to the public. The question of how effective the vaccines really
are is hardly ever asked. Yet this crucial issue of efficacy – i.e., to what degree the vaccine
actually lowers the rate of new cervical cancer cases – has not been sufficiently evaluated, and
is the object of misleading information.
STIKO made its recommendations before the relevant studies were published
In March 2007 the “Ständige Impfkommission” (STIKO) [Standing Vaccination Committee]
of the Robert Koch-Institute recommended the HPV vaccine for all girls aged 12-17 years to
decrease the burden of disease due to cervical cancer. However, at the time the
recommendation was made, the results of the decisive studies had not yet been published.
It was not until May 2007 that the most important studies on the Gardasil® vaccine, FUTURE
I and FUTURE II, were published in The New England Journal of Medicine (NEJM). The
central message of an editorial published in this journal more than one year later was: “The
bad news is that the overall effect of the vaccines on cervical cancer remains unknown” (Haug
2008)1. The most important study on the second vaccine, Cervarix®, was published in June
2007. Cervarix® has not yet been approved in the USA.
What do studies and other documents say about the efficacy of the HPV vaccines?
Cervical cancer is closely associated with HPV infection. Of the approximately 100 known
strains of HPV, at least 13 can trigger cervical cancer. Strains 16 and 18, which are the target
of these two vaccines, are assumed to be responsible for 70% of all cervical cancer cases.
However, rather than assessing the effect of the vaccine against cervical cancer, the studies
examined the incidence of high-grade cervical lesions (a potential precursor of cervical
cancer) in 15-26 year-old women.
The vaccine did achieve a 98%2 decrease in the precancerous stages associated with HPV 16
or 18 in women who had not yet been infected with these two strains. This gave rise to much
optimism, and it was widely proclaimed that the 70% of cervical cancer cases associated with
HPV strains 16 and 18 could be almost completely prevented (thus achieving a decline in all
cervical cancer cases of almost 70%). This assumption, however, has so far not been
confirmed by studies.
In analyses which included all women enrolled, FUTURE I found a decline of 7.8%3 in the
incidence of all high-grade cervical lesions (number extracted from EMEA [European
Medicines Agency] 2008), and FUTURE II a decrease of 17%.4 These evaluations have not
yet been considered by STIKO. Regarding the second vaccine, Cervarix®, STIKO based its
recommendations exclusively on data on the prevention of persistent infections. Data
regarding the efficacy of Cervarix® against precancerous stages or cancer were not yet
available.
The efficacy of Gardasil®, which has been described as “modest”, was partially explained by
the fact that some of the women examined had already been infected with HPV 16 or 18. It is
well known that the vaccine does not work once women have been infected. Hence it was
Nostrabrucanus 