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[e-drug] Offshore clinical trials, ethical violations and (non)-transparency

E-DRUG: Offshore clinical trials, ethical violations and (non)-transparency

Dear all,

The Berne Declaration has conducted extensive international investigations on 
the issue of the offshoring of industry-sponsored clinical drugs trials in 
developing and emerging countries. Researches carried out in 
Argentina<http://www.evb.ch/cm_data/1309_ARGENTINA_Final_Report_ENG.pdf> and 
India<http://www.evb.ch/cm_data/1309_INDIA_Final_Report.pdf> have shown 
multiple ethical violations due to weak regulatory environments and inadequate 
ethics monitoring. Another enquiry conducted in 
highlighted the current flaws at the Swiss medicines agency level in terms of 
ethical controls as well as the total lack of transparency prevailing during 
the marketing authorisation process.

Ethical violations such as improper informed consent process, abusive use of 
placebo, absence of post-trial treatment access and lack of compensation in 
case of serious adverse events have been documented in 4 the different country 
reports, which have just been published in English. The report about Swissmedic 
shows the risk of double protection standard of human beings participating in 
clinical trials depending where the latter take place, given the passivity of 
the drug regulatory authorities in wealthier countries - echoing the current 
debates at the European Union level with regards to regulation of clinical 
trials and access to research data.

The business model of pharmaceutical companies revolving around patent 
protection acts as an incentive to reduce the duration of the R&D phase of a 
medicine, thereby increasing the risk of ethical violations during clinical 
trials, in particular those offshored in weak regulatory environments.

A special 
 entitled "Clinical trials: human guinea-pigs on the cheap" gives an overview 
of the situation and summarises the results of our investigations as well as 
our demands to the Swiss health authorities for increased transparency and 
ethical control.

All these reports can be freely downloaded at 
www.ladb.ch/clinicaltrials<http://www.ladb.ch/clinicaltrials>. Do not hesitate 
to use and disseminate widely

Best regards

Patrick Durisch
Déclaration de Berne - Berne Declaration
Patrick Durisch
Responsable Programme Santé - Health Programme Coordinator
Av. Charles-Dickens 4, CH - 1006 Lausanne
Tel. direct: +41 21 620 03 06
Fax: +41 21 620 03 00
Email: durisch@ladb.ch
Web: <http://www.ladb.ch/>

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