MHRA accoglie querela contro Gardasil (32)

settembre 13, 2007 a 9:42 am · Archiviato in clinica, diario, Diritti, Farmaci, Gardasil, Iniziative, Merck, politica, Presente, Pubblicità, Sperimentazioni, Vaccino, Varie ed eventuali, Vi presento...

 Cos’è il MHRA?

http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&nodeId=20

• The Medicines and Healthcare products Regulatory Agency (MHRA) is the government agency which is responsible for ensuring that medicines and medical devices work, and are acceptably safe.

• No product is risk-free. Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks.

• We keep watch over medicines and devices, and we take any necessary action to protect the public promptly if there is a problem. 

• We aim to make as much information as possible publicly available.

• We enable greater access to products, and the timely introduction of innovative treatments and technologies that benefit patients and the public.

• We encourage everyone – the public and healthcare professionals as well as industry – to tell us about any problems with a medicine or medical device, so that we can investigate and take any necessary action.

Tradotto e sintetizzato si tratta dell’Agenzia governativa inglese per la farmacosorveglianza, cioè si occupano di accertare che i farmaci e i prodotti per la salute funzionino e siano sicuri.

La MHRA ha pubblicato in data 18 giugno 2007 il risultato di quella che potremmo chiamare un’istruttoria svolta dietro querela.

Advertising complaint – Gardasil (human papillomavirus vaccine) – British Medical Jurnal (BMJ) 30 march 2007 advertisement – April 2007

A healthcare professional complained to the MHRA about an advertisement for Gardasil produced by Sanofi Pasteur MSD which was published in BMJ of 30 March 2007.  The complainant was concerned that the advertising claim “reduces the incidence of pre-cancerous vaginal lesions” was misleading since the supporting data quoted was “not statistically significant”.  The MHRA had vetted prior to issue a journal advertisement for Gardasil that included a similar claim.

The MHRA upheld the complaint.  The advertiser agreed to withdraw the claim from the advertisement.

Date case raised:  30 April 2007
Date action agreed:  31 May 2007
Date of publication: 18 June 2007

Un professionista della salute, in data 30 aprile, ha querelato la casa farmaceutica Merck per pubblicità ingannevole. Nello specifico si fa riferimento ad una pubblicità pubblicato su una prestigiosa rivista, il British Medical Jurnal, in data 30 marzo 2007, in cui si dichiara ““reduces the incidence of pre-cancerous vaginal lesions” il Gardasil “riduce l’incidenza delle lesioni vaginali pre-cancerose”

Il Gardasil riduce l’incidenza delle lesioni vaginali pre-cancerose?

Secondo il querelante …the supporting data quoted was “not statistically significant”. I dati a supporto non sono “statisticamente significanti”

Secondo l’Ente governativo di farmacovigilanza pure.

La querela è stata accolta: “The advertiser agreed to withdraw the claim from the advertisement” L’inserzionista accetta di ritirare la pubblicità. 

 

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C’è già il post successivo pronto: in Canada è bufera sul Gardasil, ma questo sulla pubblicità ingannevole merita spazio. Se volete potete già leggere l’articolo della bravissima Judith Siers-Poisson’s blog:

Debating Gardasil in Canada 

 

….Oggi infuria anche in rete e sul NEJM:

Human Papillomavirus Vaccine

http://content.nejm.org/cgi/content/full/357/11/1154

…. scommesse su come trascorrerà oggi la mia giornata?

… 😦

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