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“Is progression-free survival time predictive of overall survival? Analysis of studies of targeted therapies in oncology”

 

 

 

 

“Is progression-free survival time predictive of overall survival? 

Analysis of studies of targeted therapies in oncology”

by G. Delépine, N. Delépine, S. Alkhallaf

 

presented in Bobigny congress  2017

 

 

Introduction

The duration of progression-free survival (PFS) is the first criterion of judgment of more than 90% of the trials of the current innovative therapies at the time of the MA application. This PFS is supposed to be predictive of overall survival and therefore of future usefulness for patients. This work aims to verify it as well as its predictive value of clinical utility for patients.

 

Method

A computerized search with key words Avastin, Herceptin, Erbitux, erlotinib, sorafenib, gefitinib, crizotinib, afatinib, temsirolimus, pazopanib, sunitinib, axitinib, in bronchopulmonary squamous cell carcinoma, kidney, colon, breast and ENT was realized. 110 trials were then examined to select those where SPP and long-term outcomes were published detailing overall survival and toxicity (51 studies). The gains in progression-free survival durations reported in the pivotal study were then compared to those of overall survival.

 

Results

The progression-free survival gains reported by the pivotal studies of targeted therapies are not correlated with a possible overall survival benefit or with a potential gain in quality of life. This result confirms many macroanalyses including those of Petrelli and the Cochrane Institute (for TKI and lung cancers), and the Cochrane Institute (for Avastin and breast cancer).

 

Conclusions

In trials of targeted therapies in oncology, the duration of progression-free survival does not prejudge either the overall survival time or a favourable benefit / risk balance. Favouring this criterion to award the AMM results in exposing patients to significant risks and most often without any real benefit. It should therefore no longer be accepted as the main crite

 

“Are the results of pivotal studies in oncology reliable?” in Overconsumption, overtreatment Bobigny congress 2017

 

 

colloque bobigny 2017 resultats-pivots

Colloque_2017_bobigny-poster-SSP_G_DELEPINE

two presentations in french  with curves of the results

 

“Are the results of pivotal studies in oncology reliable?”

by G. Delépine, N. Delépine, S. Alkhallaf

 

 

 

Introduction

Over the last fifteen years, the authorization to put innovative therapies on the market has been granted after one or sometimes two short placebo-controlled studies on a small number of patients. To see if these pivotal studies are reliable, we compared their initial results with the latest published results.

 

Material and methods

A computerized search with key words Avastin, herceptin, erbitux, erlotinib, sorafenib, gefitinib, crizotinib, afatinib, temsirolimus, pazopanib, sunitinib, axitinib, in bronchopulmonary squamous cell carcinoma, kidney, colon, breast and ENT cancers has been realized to find 42 pivotal studies. We then looked for those with distant results specifying the duration of progression-free survival, Overall survival and toxicity were published (32) and compared the results of the pivotal studies with those of the last trials on these three criteria.

 

Results

Less than 30% of the results presented to the regulatory agencies during marketing authorization applications are fully confirmed by subsequent trials. 20% of them are confirmed for 1 or 2 criteria. The discrepancies observed between initial and late results are always in the direction of greater efficacy or less toxicity of the new drug in the pivotal study.

 

Conclusions

In targeted therapies of solid tumors the favourable initial results of the pivotal studies are rarely confirmed by subsequent publications and the discrepancy still favours the new drug, suggesting that many of these trials do not represent real population use and that some of them benefited from the  » improvement  » of their results before presentation to regulatory agencies.

 

 

Conference « Overconsumption, overtreatment » of Medicine Faculty of Bobigny, Seine Saint Denis (France)

Summary of a communication (April 2017)

 

 

SEE  THE POSTER http://surmedicalisation.fr/?page_id=4556#Gerard_DELEPINE1  IN FRENCH

 

 

 

 

Démantèlement de la Sécurité Sociale de 1945 par loi Juppé 1996 et suivantes. Le trou existe-t-il ?

 

 

 

sécurité sociale créée par le conseil national de la résistance, sous la direction de Pierre Laroque, les ordonnances seront publiées par le Général de Gaulle en octobre 1945

la gestion est paritaire, privée, sans intervention de l’état qui va s’immiscer progressivement jusqu’à transformer la sécu de 1945 en fantôme agonisant ..  progressivement  (premières grosses attaques dès 1967).

la santé a été mise sous tutelle de l’état par la création des agences régionales  d’hospitalisation dès 1996 par les ordonnances Juppé et parallèlement par le démantèlement de la sécurité sociale

pour voir le détail de la destruction progressive de cette création  majeure du CNR conseil national de la résistance

voir le diaporama ci- dessous

démantèlement de la séc soc 2019

 cliquez sur ce lien 

 

 

dans le paragraphe suivant, lisez un extrait du site du ministère : vous  découvrez la philosophie des gouvernements successifs depuis une vingtaine d’années  aboutissant à la chute du classement du système de santé au premier rang en 1996 avant la mise sous tutelle bureaucratique de la médecine.

actuellement très mal classée (perte de 25 places en 20 ans) les conséquences sont vues quotidiennement par tous : grève des urgences, de la psychiatrie,  fermeture des maternités etc.. Tragique déclin qui ne cessera qu’avec la prise de conscience des citoyens qui alors exigeront la suppression de la tutelle bureaucratique sur l’exercice de la médecine.

 

 

extrait du site du ministère www2.assemblee-nationale.fr/decouvrir-l-assemblee/role-et-pouvoirs-de-l-assemblee-nationale/les-fonctions-de-l-assemblee-nationale/les-fonctions-legislatives/l-examen-parlementaire-des-lois-de-finances

Fiche de synthèse n°41 : L’examen parlementaire des lois de financement de la sécurité sociale

Fiche précédente

Fiche suivante

« Fiche mise à jour le 19 juin 2017

Alors même que les masses financières en jeu sont supérieures à celles du budget de l’État, le contrôle de la politique du Gouvernement en matière de sécurité sociale échappait très largement au Parlement en raison du fonctionnement et du financement originellement paritaires de la sécurité sociale. Dès lors que l’impôt, et non plus seulement les cotisations sociales, est devenu une source majeure de financement des dépenses de sécurité sociale, le Parlement, depuis plus d’une vingtaine d’années, se prononce désormais sur cette question.

Encadrées par des dispositions constitutionnelles complétées par une loi organique, les conditions d’examen annuel des projets de loi de financement de la sécurité sociale (PLFSS) par l’Assemblée nationale se distinguent de celles des projets de loi ordinaires.

(1) Loi constitutionnelle n° 96-138 du 22 février 1996 instituant les lois de financement de la sécurité sociale. »

 

NB

 

on en est loin ! A nous tous de se battre pour la reconstruire

Gardasil, a risky vaccine: paradoxical cervix cancer increasing rate in vaccinated population

15 5 2019 gardasil chicago (002) 5     diaporama 

Paradoxical oncologic results of Gardasil in the real world. A cancer registers study.

Dr G Delépine, surgeon oncologist, Paris, France[1] N Delépine paediatric oncologist, Paris, France[2]

Oral presentation by Dr G Delépine 24 th of may 2019 Chicago Illinois USA

Summary

Aim: the authors evaluate the results of HPV vaccination on the incidence of invasive cervical cancer in different countries, comparing published data in national cancer registries and those of HPV vaccine coverage.

Method. After collecting crude figures and standardized incidences from oncologic registers of Australia (Australian Institute of Health and Welfare), Great Britain (Cancer research UK), Sweden and Norway (Nordcan), they analyse the evolution and their tendencies before and after the era of vaccination in the different countries and different age groups, with a particular attention to 20-29 age groups(high vaccine coverage).

Results In all studied countries, these evolutions are similar. During the 1989-2007 ( pre-anti HPV vaccination period), the incidence of invasive cervical cancer declined in all countries, results linked with smear screening.

Vaccination campaigns were initiated in 2007 (Australia) or 2008 (Great Britain), and we have now 7 to 9 years of follow up. Since 2007, a trend reversal has been observed in all countries with high immunization coverage studied (Australia, Great Britain, Norway, Sweden). Their official cancer registries reveal an increase in the incidence of invasive cervical cancer that appears 3 to 5 years after the beginning of the vaccination campaign and affects almost exclusively the age groups the most vaccinated.

In 20-24 group the increase reaches 100% in Sweden (1.86/100000 in 2007 vs 3.72 in 2015), 70% in Great Britain, (2,7 in 2007 vs 4,6 in 2014), 113% in Australia (0.7 vs 1.5), 10% in Norway (2.18 in 2007 vs 2.4 in 2015). In the 25-29 age groups, the increase reaches 100% in Great Britain (11 in 2007 vs 22 in 2016), 36% in Australia (5.9 in 2007 vs 8 in 2014), 9% in Norway (5.9 in 2007 vs 8 in 2015),10% in Sweden.

The crude figures are small, and, for this reason, the differences are individually not all statistically significant, but their convergence constitute a strong alarm signal, while unvaccinated (older women) have their risk of cervical cancer stabilized or continuing to decrease.

Comments. The contrast of the increasing rate of invasive cancer despite nearly eradication of HPV viruses after vaccination is paradoxical.

For vaccinated women, the evolution is dramatic. In France, a country with low vaccination coverage (<20%), the world standardized incidence rate of cervical cancer continues to decline in all age groups and is now lower (2017ASR 6/100000) than of more vaccinated countries

Conclusion. This unexpected paradoxical result, absolutely distressing for vaccinated women, requires additional studies to determine as quickly as possible the causes of such a health disaster and justifies an immediate review of vaccine recommendations.

[1] No link of financial interest with any drug company or anti-vaccine association

 

[2] Idem 1

 

CONFERENCE DR N DELEPINE A SAINTES : GARDASIL PROCHAIN SCANDALE SANITAIRE ?

LE DIMANCHE  30 JUIN 2019

 

REJOIGNEZ NOUS POUR LA CONFERENCE 17 h 30 à 19 h : Docteur Nicole Delépine : CONFERENCE SAINTES JUIN 19

« Pourquoi chaque jour apporte-t-il  un nouvel article publicitaire trompeur dans les grands médias ? Pourquoi les députés déposent-ils un amendement pour rendre ce vaccin obligatoire et la ministre se prononce pour l’élargissement de la vaccination aux garçons ? Pourquoi tant d’émissions répandent-elles la peur chez les familles des jeunes femmes et bientôt des garçons ? Ainsi, en l’absence de prise de conscience rapide, le gardasil et les 11 vaccins obligatoires pourraient  bien être le prochain scandale sanitaire. »

CONFERENCE QUI SE TIENDRA DANS LE CADRE DES CHANTIERS DU FUTUR

 

21 ième université de l’Environnement et de la Santé 29 juin au 4 juillet 2019

LES CHANTIERS DU FUTUR

Parc des Expositions à Saintes (17) Renseignements : 05 46 90 52 77
E N V I R O N N E M E N T • S A N T É • P R É V E N T I O N

Conférences et Salon au Parc des Expositions Hall Mendès France Cette Université s’adresse à tous ceux qui se sentent responsables de leur environnement et de leur santé.

espace artisans, ateliers

Samedi de 10 h à 19 h Du dimanche au mercredi de 9 h à 19 h Jeudi de 9 h à 18 h Fermé le lundi matin  « Appareils de bien-être, thérapies quantiques, médecine de l’habitat, chaussures écologiques, semences anciennes, textiles bio, cosmétiques et produits d’entretien bio, huiles essentielles, création artisanale de vêtements, plantes Aloé Vera, produits régionaux, sel détachant… Stand de dédicaces des livres des conférenciers, documentations.

ENTRÉE DU SALON GRATUITE  »
Restauration Bio “L’Epiphyte Cantine Nomade” Buvette des Chantiers du Futur
Visitez notre site : www.leschantiersdufutur.fr 

Conférence du Docteur Gerard Delépine à Chicago à propos des résultats paradoxaux du Gardasil : augmente le taux de cancers du col chez populations vaccinées

Le Gardasil un surtraitement préventif au résultat cancérologique paradoxal présentation orale+poster colloque de Bobigny 2019

Venez participer au colloque annuel de Bobigny :   Colloques de Bobigny

et en particulier à nos présentations

 

nous y présenterons un résumé de nos travaux sur Gardasil et cancer 

samedi 25 Mai atelier n° 3 Les vaccins.  10 H30 -12H30

 

 » Les « Colloques de Bobigny », constituent la première manifestation scientifique et de réflexion sur la thématique « Sous-médicalisation, Surmédicalisation, Surdiagnostics, Surtraitements », déjà organisée à sept reprises en France par le groupe d’initiative Princeps, avec le concours de :

– Le Département de Médecine Général de la Faculté de Médecine de Bobigny,

– La Société de Formation Thérapeutique du Généraliste

– L’Association « Civic Santé »

Ce colloque se tiendra, sous le patronage du Doyen de la Faculté de Médecine de Bobigny (UFR SMBH), les vendredi 24 et samedi 25 mai 2019, Faculté de médecine de Bobigny (entrée avenue de la Convention)

Le montant de l’inscription est de 40 euros (20 euros pour les étudiants et Internes en Médecine).

Ces frais d’inscription très limités, qui comprennent les accueils et pauses café, le repas de midi du vendredi, et l’intendance du colloque, ne sont possibles que grâce aux locaux mis à disposition par la Faculté de médecine de Bobigny, et l’engagement de la SFTG. Cette modeste somme est le prix de notre indépendance.

Les inscriptions doivent être adressées à la SFTG, 233 bis rue de Tolbiac 75013 Paris, avec la mention « Colloque de Bobigny ». L’inscription en ligne est possible : ici.

Vous pouvez également télécharger ici le bulletin d’inscription, le remplir et l’adresser à la SFTG

N’hésitez-pas à diffuser à vos réseaux ou connaissances cette invitation Le groupe Princeps »

 

Gardasil: faith and propaganda versus hard evidence

Faith and propaganda versus hard evidence

The road to hell is paved with good intentions

 

In a recent news: « Cervical cancer: deaths increase as HPV vaccine is underused, says WHO »[1] published in British Medical Journal, Owen Dyer pleas for of anti HPV vaccines  on the faith that this vaccine can prevent invasive cervix cancer. This golden tale is respectable but relies only on « predictions, » not on scientific hard evidences of real oncologic results. He acts as a new advocate of vaccination promising for now more than 15 years that cervix cancer will disappear in 20 years but forget to watch to oncologic results already published in cancer registries!

These real oncologic results are paradoxical and really worrying: In all the countries with high anti HPV coverage the incidence[2] of invasive cervix cancer increases in vaccinated age groups while in older (unvaccinated) population and in France, (with low vaccine coverage) the incidence diminishes.

 

The Myth of Australian success

Australia was the first country to organize routine immunization for girls aged 12 to 26 in 2007 and is always cited as the example of success of vaccine on the belief of a simulation presented as real results[3]. But, according to the cancer register[4], vaccinated age groups women suffer from risk increase: 113% (from 0.7 to 1.5) for those aged 20 to 24 (catch up vaccinated for more than 80% of them), about a third increase for 25-29 y women (p<0.05) and for 30-34 who are less vaccinated, (p=0.01). These last increases are statistically significant and cannot be due to hazard. During the same period, most older women (and therefore unvaccinated) saw their cancer risk decrease : less 17% for women aged 55 to 59 (from 9.7 to 8.1), less 13% for women aged 60 to 64 ( from 10.3 to 8.9), less 23% for those aged 75 to 79 (from 11.5 to 8.8) and even less 31% for those aged 80 to 84 (from 14.5 to 10).

 

 

 

GREAT BRITAIN: THE PARADOXAL EFFECT OF GARDASIL PROMOTING CANCER

The UK national program was introduced in 2008 to offer HPV vaccination to 12–13-year-old with catch-up vaccination to girls up to 18 years old. Vaccination coverage in England has been with over 80% of 12–13-year olds receiving the full course. Coverage within the catch-up cohorts ranges from 39% to 76%). As related by Castanon « We expected cervical cancer rates decrease in women aged ages 20 to 24 from 2014… However, in 2016, national statistics showed sharp and significant increase in the rate of cervical cancer in the vaccinated age groups. Women aged between 20 and 25 years vaccinated for more than 85% of them, saw their cancer risk increase by 70% in 2 years (from 2.7 in 2012 to 4.6 per 100,000 in 2014 p = 0.0006)[5], and those aged 25 to 30,  who were aged between 18 and 23 at the time of the vaccination campaign saw their cancer risk increase by 100% between 2007 and 2015 (from 11 / 100,000 to 22 / 100,000 )”. According to Office of National Statistics Women 25 to 34 years, less vaccinated, have seen incidence increase by 18% (from 17 in 2007 to 20 in 2014).  Older, women unvaccinated, benefit of stable or decreasing incidence (-13% for 65-79, 10% after 80.

 

 

 

 

 

 

 

SAME PARADOXICAL PHENOMENON IN SWEDEN.

In Sweden, Gardasil has been used since 2006, and the vaccination program was rolled out in 2010, with vaccination coverage of 12-year-old girls approaching 80%. In 2012-2013, with a catch-up program, almost all girls aged 13 to 18 were vaccinated.  In this country, the standardized incidence of cervical cancer in the global [6]population has increased steadily since vaccination from 9.6 per 100000 in 2006 to 9.7 in 2009, 10.3 in 2012 and 11.49 in 2015[7]. This increase is mostly due to the increase in the incidence of invasive cancers among women aged 20-24 whose incidence doubled (from 1.86 in 2007 to3.72 in 2015 c=0.89; p<0.001). The incidence of invasive cancer of the cervix increased by 24% in women aged 25 to 34 from 12.44 to 15.49(c=0.68; p=0.05), In contrast, a decrease in the incidence has been observed in women over 50. Dillner, a promoter of vaccination recognizes the increase of incidence of cancer in his country [8] but pretends that « less effectiveness of screening » is the culprit

Advocates of vaccination brandish good results against infection by stains included in the vaccines and decrease of CN2 CN3. But they should rather watch on registered cancer incidences and wonder about the paradoxical contrast of decrease of infection and statistically significant increases of invasive cancer. This paradox questions the causal Link between HPV infection and cancer and the repeated mis information pretending that 99% of cervix cancer are only due to HG HPV[9] 

 

 

 

 

France: the bad example for big pharma

 

 

 

The evolution of these countries, with high immunization coverage, can be compared to the trend observed in metropolitan France, where HPV vaccination coverage is very low (around 15%). France can be considered, for this reason, as a control country. In France the incidence of cervical cancer has steadily decreased from 15 in 1995 to 7.5 in 2007, 6.7 in 2012 and 6 in 2017, much lower than the countries with high vaccine coverage. This decrease in incidence was accompanied by a decrease in mortality from 5 in 1980 to 1.8 in 2012 and 1.7 in 2017.

It is paradoxical and very worrying that this favourable French evolution, could be jeopardized by an obligation considered in the short term by our representatives[10], for some misinformed and other with too much competing interests with big pharma

 

[1] BMJ 2019;364: l580 doi: 10.1136/bmj. l580 (Published 6 February 2019)

[2] Incidence = number of new annual cases/100 000 women

[3] BBC Cervical cancer: Australia ‘to be first to eliminate disease’2018 10 3 https://www.bbc.com/news/world-australia-45727977

[4] Australian Institute of Health and Welfare

[5] Castanon A. Sasieni P. Is the recent increase in cervical cancer in women aged 20–24 years in England a cause for concern? Preventive Medicine 107 (2018) 21–28

[6] Cytological begnin abnormalities linked to infections

[7] According to Nordcan. register

[8] Dillner Joaquim: Livmoderhals cancer ökar hosbkvinnor med normalt cellprov Läkartidningen

Volym 115 article in swedish

[9] Ibid Already cited BBC 2018 10

[10] Their representativity is questioned by the « yellow coats

Hystérie vaccinale, Gardasil et cancer, un paradoxe NOUVEAU LIVRE 2018

Devant la découverte de l’effet paradoxal du vaccin Gardasil qui augmente le risque du cancer du col de l’utérus chez les femmes vaccinées de façon systématique dans tous les pays dont le taux élevé de sujets vaccinés, permet une analyse statistique significative, nous avons décidé d’approfondir le problème, et de tenter de livrer ce travail à la population générale  le fruit de cette découverte.

La présentation du DR G Delépine, chirurgien et statisticien, à Perpignan le 23 Novembre 2018  détaille les courbes comparatives de taux de cancer du col de l’utérus, avant et après vaccination large des populations.

Gardasil G Delépine 22 11 2018 présentation Perpignan

n’hésitez pas à ouvrir le diaporama, ou à nous joindre si vous avez des questions, suggestions, commentaires