Dubious clinical trial practices in India and China

Publié le : 13 December 2013

 Two thirds of clinical trials relating to medicinal products available on the European market are conducted outside Europe, namely in India or China. The practices have been managed inappropriately with tests being performed unbeknown to the individuals concerned. There are also claims of falsification of results and analytical errors, etc.

In India, scandals have led the Supreme Court to suspend "all authorisations for clinical trials until the government implements new legislation governing such practices". This decision was made in the light of worrying facts. In early 2013, "survivors of the Bhopal industrial disaster learned that they had taken part in clinical trials: the hospital constructed to provide free treatment for explosion victims […] had conducted clinical trials on cancer patients between 2000 and 2011 without informing or remunerating them". Furthermore, two vaccines against cervical cancer, Gardasil (Merck & Co) and Cervarix (GlaxoSmithKline), "would have been tested on young female Aborigines by the American non-governmental organisation, Path, without parental permission. Between 2005 and 2012, the authorities officially recorded eighty deaths during the clinical trials. The government should improve legislation in four areas: 1/the filmed recording of parental consent, 2/a review of compensation, 3/the introduction of criminal proceedings when an error can be attributed to a doctor, 4/a restrictions on companies/organisations to conduct clinical trials only in public hospitals or centres approved by independent expert committees. However, according to Sourirajan Srinivasan, Director of the NGO Locost, "these new regulations do not go far enough". He pointed out that, "Currently, only 10% to 15% [of those conducting clinical trials] actually have the skill set required". 
In China, there have been several medical repercussions. The American Health authorities, the FDA, delayed the marketing of a new anticoagulant, Eliquis (Bristol-Myers), after having discovered "the manipulation of formulations, non-compliant prescriptions and unreported side effects" in 2012. In June of the same year, the GlaxoSmithKline Laboratory dismissed its R&D director following the "incorrect presentation" of data based on a study published in 2010 on multiple sclerosis. It seems that these repercussions were due to "public hospital under-funding" ­– the root cause of major problems.

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