New campaign for fair drugs testing aims to combat exploitation worldwide
The Netherlands - People in developing countries run health risks from pharmaceutical companies testing drugs on them for the Western market.
An Indian Centre for Studies in Ethics and Rights research report (published 5 February) has again shown that several pharmaceutical firms disregard ethical rules. On the same day, a worldwide campaign — FairDrugs.org – was launched by a worldwide coalition of health organisations and scientists, led by the Dutch Wemos Foundation, which contributes to the structural improvement of people’s health in developing countries.
One of the study’s investigations focused on the way a pharma company tested a breast cancer drug on seriously ill women, a drug that has been conditionally approved for the European market by the European Medicines Agency, said Annelies den Boer of the Wemos Foundation, co-commissioner of the study with the Centre for Research on Multinational Corporations (SOMO). Women’s participation in the trial in India was ‘… practically inevitable, since it was the only treatment option available to the women. They just had to accept the risks entailed in an experimental drug,’ she added.
About 400,000 Indian women have breast cancer, most of them cannot afford to pay for the treatment they need. Annelies den Boer said the pharmaceutical firm ‘… has taken advantage of their vulnerable position’ adding that, although the drug is now available in India, most breast cancer patients cannot afford it.
Tjalling van der Schors, hospital pharmacist and member of a Dutch medical ethics committee, is also critical of the trial, saying it would never have been passed by a Dutch ethics committee: ‘You only give cancer patients experimental treatments if normal protocols no longer work.’
Another pharmaceutical giant was also named for conducting clinical trials in India that are not accepted by ethical review committees in Western Europe. The trials involved giving placebo treatment to schizophrenia patients. The Indian report indicates that these trials were not required for obtaining marketing authorisation in India. Annelies den Boer commented: ‘Time after time we see that patients in developing countries are used to test drugs that are primarily intended for the European market. Contrary to the ethical guidelines, these patients do not benefit from the research results. It’s high time for firm action from the European authorities charged with the approval of new medicines and their admission to the European market.’
The campaign
‘We’ve issued a call urging policy-makers, regulators and pharmaceutical companies to respect the rights of trial subjects in developing countries,’ explained Annelies den Boer. ‘Everyone who signs the call at www.FairDrugs.org is also giving support to our European lobby action.’
* Wemos details are on the same website. Further information: leontien.laterveer@wemos.nl. Phone: Leontien Laterveer: +31 (0)20 – 435 20 62 or +31 (0)6 – 10 30 58 90.
01.03.2009
