UNETHICAL CLINICAL TRIALS IN DEVELOPING COUNTRIES

A new evidence has emerged that some drugs have been unethically tested in low-income and middle-income countries and are being given approval for use on the European market.

In a press released by the Centre for Research on Multinational Corporations (SOMO) and the Wemos Foundation on 19th February 2008, European citizens are literally depicted to be swallowing “bitter” pills or “unfair” drugs.

SOMO analysed the justification for the use of placebos and the participation of vulnerable patient groups in phase III clinical trials.
The report shows that European authorities grant EU marketing authorization based on clinical trials which are unethical. It also demonstrates that these authorities actually encourage unethical trials in countries outside Western Europe by requiring trials that are no longer accepted by the ethical Review committees in Western Europe.
As a result, controversial trials end up being conducted in low-income and middle-income countries where local regulatory authorities and ethical review committees are ill-equipped to cope with the enormous upsurge in the number of clinical trials.
For example, in one placebo-controlled trial to test Seroquel XR, an antipsychotic drug for the treatment of patients with schizophrenia, a 25-year old man committed suicide after 173 days of placebo (no drug) treatment. Also, 8.3% of the patients receiving a placebo required hospitalization due to worsening of their disease. This trial was conducted in Bulgaria, India, Poland, Russia and Ukraine and was only aimed at investigating the differences between formulations of the same antipsychotic. According to the Declaration of Helsinki, this type of trial can never justify the use of a placebo because it involves withholding treatment from seriously ill patients. Nevertheless, the Dutch Medicines Evaluation Board (CBG) approved Seroquel XR for the EU market. The CBG is legally required by EU Directives to publish (public assessment report for Seroquel) without delay, but at the time the SOMO report was made, it was still not available. This lack of transparency is not limited to the Seroquel case. In general, SOMO has experienced great difficulty in obtaining information about where clinical trials were conducted and which ethical considerations were made Do we have clinical trial guidelines in Nigeria? NAFDAC and all relevant agencies must be alert to these international conspiracies. Full SOMO report is available at: www.somo.nl/html/paginas/pdf/Ethics_for_Drug_Testing_feb08_EN.pdf The WEMOS report is available at:
www.wemos.nl/Documents/a_bitter_pill.pdf

For more information, please contact: • Irene Schipper, SOMO senior researcher, on +31 20 6391291, e-mail: i.schipper@somo.nl; or • Leontien Laterveer, Wemos Communications Officer on Medicines, on +31 20 4352050; e-mail: leontien.laterveer@wemos.nl