Are GSK and AZ's "off-shore" drug trials ethical?

Amsterdam, 5 February 2009 – People in developing countries run health risks from pharmaceutical companies testing drugs on them for the Western market. An Indian research report published today again shows several pharmaceutical companies’ disregard for ethical rules.

Lapatinib

‘The Indian Centre for Studies in Ethics and Rights has examined, among other things, the way GlaxoSmithKline tested a breast cancer drug on seriously ill women in India,’ says Annelies den Boer of the Dutch Wemos Foundation, co-commissioner of the study with the Centre for Research on Multinational Corporations (SOMO). ‘The drug, lapatinib, has been conditionally approved for the European market by the European Medicines Agency.’

Breast cancer

There are currently around 400,000 Indian women with breast cancer, most of whom cannot afford to pay for the treatment they need. Den Boer says: ‘Participation in the lapatinib trial 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. GlaxoSmithKline has taken advantage of their vulnerable position. By now lapatinib is available in India, but 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.’

Placebo

Pharmaceutical company AstraZeneca also conducted clinical trials in India that are not accepted by ethical review committees in Western Europe. The company gave placebo treatment to patients with schizophrenia. From the report published today it becomes clear that these trials were not required for obtaining marketing authorization in India. Den Boer says: ‘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.’

Campaign

FairDrugs.org, a campaign by a worldwide coalition of health organizations and scientists led by Wemos, starts today. Den Boer says: ‘We’ve issued a call urging policy-makers, regulators and pharmaceutical companies to respect the rights of trial subjects in developing countries. Everyone who signs the call at www.FairDrugs.org is also giving support to our European lobby action.’

Press note

Wemos contributes to the structural improvement of people’s health in developing countries. For more information go to www.FairDrugs.org or contact Leontien Laterveer (Wemos): +31 (0)20 – 435 20 62; +31 (0)6 – 10 30 58 90; leontien.laterveer@wemos.nl.