Ethics for Drugs Testing in Low and Middle Income Countries
SOMO: Stichting Onderzoek Multinationale Ondernemingen | Centre for Research on Multinational Corporations
(…) “Seroquel (quetiapine fumarate) is a drug for schizophrenia that was approved in the EU in 1999. A once-daily extended release formula, Seroquel XR, was approved in August 2007 by the Medicines Evaluation Board (MEB) of the Netherlands. Two placebo-controlled trials that were submitted to obtain marketing authorisation for Seroquel XR started in November 2004 and March 2005. Denying existing treatment to acutely ill and stable schizophrenia patients is unethical according to the Declaration of Helsinki, and no justification was given for placebo use. The stable schizophrenia patients receiving placebo clearly experienced harm from their participation in the trial as they had an estimated 68% risk of a psychiatric relapse in six months versus 14% for patients receiving Seroquel XR. 8.3% of the patients receiving placebo had to be hospitalised due to worsening of schizophrenia and one 25 year-old patient committed suicide after 173 days of placebo treatment. What is especially striking in this case is that these trials are set up only to investigate the differences between formulations of the same antipsychotic which never justifies the use of placebo. Nonetheless, the results of the trials were accepted by the Dutch medicines agency as a valid basis to grant marketing authorisation in 2007.”
Data Sources and Methodology
(…) “In order to search the selected databases on trials carried out in low and middle-income countries, it was necessary to select a few countries and use these as free text search terms. The following countries were selected: India, Russian Federation, Mexico, Argentina, Peru, the Philippines, Kenya, and Zambia.
For the following selection of drugs, trials in low and middle-income countries could be identified following this approach:
– Abilify (aripriprazole) of Bristol Myers Squibb (BMS).
– Seroquel (quetiapine fumarate) of AstraZeneca
– Zyprexa (olanzipine) of Eli Lilly
– Crestor (rosuvastatin) sponsored by AstraZeneca
– Olmetec (olmesartan) sponsored by Pfizer/Daiichi Sankyo Seretide (salmeterol) of AstraZeneca
Risperdal (risperidone) of Johnson & Johnson
Clearly, most of the trials that were identified for low and middle-income countries involve the testing of psychotherapeutic agents. An article about a study on schizophrenia trials in China confirms this: the research identified a total number of 3,275 records of which 982 randomised controlled trials were relevant to schizophrenia. This is almost 30%35. The question as to why so many trials being offshored to countries outside Western Europe involve psychotherapeutic agents is answered by AstraZeneca: placebo-controlled trials for schizophrenia are no longer being approved by most of the Western European Research Ethics Committees (RECs).36
The drugs Abilify (aripiprazole), Seroquel (quetiapine fumarate) and Olmetec (olmesarten medoxomil) were chosen to study in more detail.”