’Testing breast cancer drug in India unethical’

A report has claimed that pharmaceutical companies are violating ethical rules when they test medicines in developing countries. Read the newsreport and feature by Joop Bouma, investigative journalist at Trouw newspaper

Manufacturer GlaxoSmithKline has unethically tested a breast cancer drug in India, says the Wemos Foundation, an Amsterdam-based lobbying organization on international health issues.

According to Wemos, GSK has ,,taken advantage of the vulnerable position of breast cancer patients’’ by conducting a clinical trial in India with the drug lapatinib, which is also registered in the Netherlands under the brand name Tyverb.

Only women with advanced or metastasized breast cancer who had not yet received chemotherapy for their illness could be enrolled in the study. According to Annelies den Boer of Wemos, the majority of the 400,000 Indian women with breast cancer cannot afford to pay for their treatment. ,,Participation in the 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.’’

In Europe it is considered unethical to expose people who are seriously ill to an experimental compound without having first tried an effective standard treatment. ,,This study would never have been approved by an ethics committee in the Netherlands’’, says hospital pharmacist Tjalling van der Schors, a member of the medical ethics committee at West Frisia Hospital in Hoorn. ,,You only give people an experimental treatment if the established therapy does not work.’’ According to Van der Schors, the unfavourable situation in India is frequently exploited.

Rudolf van Olden, GSK's Medical Director in the Netherlands, refutes the conclusions of the Indian research report. ,,We set this study up in accordance with the international ethical standards. We do not accept this criticism.’’

Wemos today embarks on a European campaign against unethical drug research in developing countries. The organization has launched a website (www.fairdrugs.org) on which healthcare organizations and scientists call for the rights of trial subjects in developing countries to be respected.

In response, the European Medicines Agency, EMEA, says that intensive efforts are being made to step up inspections in countries where clinical drug research is carried out. The EMEA has performed 189 inspections over the past decade, nine of them in India.

Van der Schors believes that this is not enough. "It would be good if the EMEA, and also the Dutch Medicines Evaluation Board (MEB), when they register products for the European market, were to investigate whether or not a study has been performed in accordance with ethical standards. At present, licensing authorities mainly look at the results of the studies."

This article originally appeared in Trouw on the 5th of february, 2009.

© Trouw 2009. This article is subject to copyright.

India a testing ground for Western medicines

Joop Bouma

Pharmaceutical company GlaxoSmithKline has tested an experimental drug for breast cancer – now also available in the Netherlands – on women in India. This practice contravenes ethical standards, according to Wemos, a lobbying organization on international health issues. Today sees the publication of a report on drug research in India.

Medicines − especially the latest products − are too costly for Indian patients to buy for themselves. But it is apparently deemed quite acceptable that they should test them.

Wemos is launching a campaign to promote ethical research in developing countries such as India. Poor countries are widely used for testing products that are ultimately mainly consumed in Western countries. GlaxoSmithKline (GSK) is highlighted as one of the major culprits in a report published today by the Centre for Studies in Ethics and Rights, based in Mumbai, India.

GSK developed lapatinib, which has also been available on the Dutch market under the brand name Tyverb since last year. The drug was granted conditional approval by the European Medicines Agency, EMEA.

Tyverb cannot be given definitive marketing authorization until further scientific data are available about the effect of the drug on breast cancer survival rates and on its metastasis. Nor has it been decided yet whether or not the drug will be reimbursed in the Netherlands. Until its reimbursement status is settled, GSK will supply lapatinib free of charge to selected patients in the Netherlands if it is requested by a doctor.

Tyverb must be taken concurrently with capecitabine (brand name: Xeloda), a Roche Pharmaceuticals drug that inhibits the growth of cancer cells.

The question is whether Tyverb is also effective when used without adding a second drug. Between July 2004 and January 2006, GSK investigated this very question at 19 research sites in 10 different countries. For the purposes of this study (performed in the United States, Chile, Hong Kong, Malaysia, Mexico, Pakistan, Peru, Singapore, Taiwan and India) the manufacturer sought out women with advanced or metastasized breast cancer, who had not previously been treated with chemotherapy.

,,Under these conditions, you soon find yourself looking at countries such as India, where not everyone enjoys access to healthcare’’, says Annelies den Boer of Wemos.

© Trouw 2010, op dit artikel rust copyright.