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

e-drug
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E-DRUG: Offshore clinical trials, ethical violations and (non)-transparency
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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 Ukraine<http://www.evb.ch/cm_data/1309_UKRAINE_Final_Report.pdf&gt;, Russia<http://www.evb.ch/cm_data/1309_RUSSIA_Final_Report_ENG.pdf&gt;, Argentina<http://www.evb.ch/cm_data/1309_ARGENTINA_Final_Report_ENG.pdf&gt; and India<http://www.evb.ch/cm_data/1309_INDIA_Final_Report.pdf&gt; have shown multiple ethical violations due to weak regulatory environments and inadequate ethics monitoring. Another enquiry conducted in Switzerland<http://www.evb.ch/cm_data/1309_SWISSMEDIC_Final_Report_ENG.pdf&gt; 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 publication<http://www.evb.ch/cm_data/DB-Solidaire-229-ang_-_septembre_2013.pdf&gt; 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&gt;\. Do not hesitate to use and disseminate widely

Best regards

Patrick Durisch
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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/&gt;