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[e-drug] Experimental breast cancer drug unethically tested on Indian women

E-DRUG: Experimental breast cancer drug unethically tested on Indian women
-------------------------------------------------

*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.

-- 

Leontien Laterveer
Senior Communicatiemedewerker
Senior Communications Officer
Tel: +31 (0)20 435 2062
__________________________________________________________________
Wemos contributes to the structural improvement of people's health in 
developing countries: /health for all/.

Wemos Foundation, P.O. Box 1693, 1000 BR Amsterdam, The Netherlands.
Tel: +31 (0)20 435 2050 / fax +31 (0)20 468 6008 / web site www.wemos.nl




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