The watchdog agency, Wemos International, which works to protect human subjects in clinical trials, today accused GlaxoSmithKline (GSK) and AstraZeneca of running unethical clinical trials in India.

GSK

GSK tested the breast cancer drug lapatinib in India.  The drug, lapatinib, has been conditionally approved for the European market by the European Medicines Agency.’

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.’

AstraZeneca

AstraZeneca conducted two trials testing a new formulation of their drug Seroquel, which is used to treat schizophrenia.  In both trials one group of participants was given the drug Seroquel and the other group was given a placebo.

Wemos International found two problems with this study.  The first was design in these trials was not necessary. Placebo-controlled trials are not required to establish the efficacy of a new formulation of an approved drug. The second is that patients on placebo – in both trials – were harmed because they were deprived of an effective treatment until they suffered a relapse.

SOURCE:  Wemos International