“Pfizer should make ethics a priority”
Amsterdam, 5 August 2009 – Pharmaceuticals company Pfizer pays out up to 53 million euros to settle legal claims relating to a controversial drug trial in Nigeria. “It’s a pity that Pfizer still won’t admit blame,” says Annelies den Boer at Wemos. “Pfizer should make ethics a priority.”
During an outbreak of meningitis in Kano (Nigeria) in 1996, two hundred children were given medicines free of charge by Pfizer. Half were treated with the established drug Rocephin (Ceftriaxone), while the other half received the experimental drug Trovan (Trovafloxacin). Eleven children died, others were paralysed or suffered brain damage.
The British documentary Dying for Drugs and investigations by the Centre for Research on Multinational Corporations (SOMO) revealed that Pfizer failed to obtain consent from the sick children’s parents before carrying out the trial. Nor were the parents told that the treatment offered was experimental. This was all the more reprehensible because an effective meningitis drug was already available, and was being dispensed in the region by the charity Médecins Sans Frontières.
Furthermore, in Dying for Drugs, it was suggested that the research protocol had not been approved by an ethical review committee and that Pfizer antedated an official letter to make it appear that such approval had been obtained in good time.
Pfizer nevertheless still refuses to admit that it did anything wrong. The company claims that the trial was conducted responsibly and that the drugs provided saved the lives of numerous children. Parental consent, Pfizer argues, was obtained verbally through a local nurse.
It is indeed the case that no direct link has been proven between participation in the trial and the deaths and residual health problems among the children. What is known is that Trovan has serious side-effects, which persuaded the European Commission to withdraw the drug’s licence in 2001.
Under the settlement with the Kano state government, Pfizer has promised to establish a fund for Trovan trial participants, to underwrite various local health care projects and to pay the state government’s legal costs. “Three of the six people on the board of the victims’ fund are to be appointed by Pfizer,” commented Annelies den Boer. “We are concerned about the implications of this arrangement for the independence of the fund.” Den Boer believes that an independent party such as the World Health Organization should have been involved in the management of the fund.
In 2008 and 2009, Wemos published reports on the ethical issues surrounding the performance of clinical trials in developing countries. The foundation wants to see tighter regulation, especially in the context of the licensing of new pharmaceuticals for the European market, and closer ethical scrutiny of trials in less prosperous countries.
Note to editors (not for publication)
For more information, please contact Leontien Laterveer, Senior Communications Officer at Wemos, phone: 31 (0) 20-4352062; mobile: 31 (0) 6-10305890, e-mail: email@example.com
The Wemos Foundation is an Amsterdam-based organization contributing to the structural improvement of people’s health in developing countries through advocacy. See www.wemos.nl
Growing support for unethical testing campaign
Amsterdam, 27 May 2009 – Last week marked the celebration of International Clinical Trials' Day 2009. A worldwide coalition of health and human rights organizations united in the campaign FairDrugs.org called for the adequate protection of trial subjects in developing countries.
The campaign, led by the Wemos Foundation, centres on the Call for Ethical Clinical Trials in Developing Countries, and appeals to policymakers, legislators and pharmaceutical companies to respect the rights of trial subjects. Numerous organizations and individuals have already signed up, including independent investigative journalist Sonia Shah, the author of The Body Hunters: Testing New Drugs on the World's Poorest Patients. ‘For too long, clinical trials in poor countries have been conducted in the shadows, endangering the human rights and health of test subjects. I support the FairDrugs.org campaign because I believe civil society must be involved to ensure that all human experimentation is conducted to the highest ethical standards. Anyone who benefits from modern medications should, too’, says Sonia Shah.
The European Medicines Agency (EMEA) recently announced its intention to improve supervision of compliance with ethical guidelines in clinical trials conducted outside the European Union (EU). This is a positive development, according to Wemos' Annelies den Boer: 'We have been expressing our concern about the increasing number of medicines being tested on people in developing countries since 2006. We have called for thoroughgoing ethical evaluations before medicines are given EU market approval. EMEA now intends to actually do this.'
'We are especially interested in how EMEA will tackle the practical application of international ethical guidelines. We hope that the latest version of the Declaration of Helsinki will be used as the starting point and that EMEA will consult experts in developing countries for advice.' Den Boer points out that the registration authorities in EU member states will also need to take action. 'Political support is essential, both at European level and within member states, if the steps proposed by EMEA are to be implemented. We see our role as one of mobilizing support and creating momentum, for example by means of FairDrugs.org.'
On International Clinical Trials' Day 2009, coalition members wrote letters to public health ministers across Europe, calling for measures to prevent further abuses of trial subjects in developing countries. Sandhya Srinivasan, editor of the Indian Journal of Medical Ethics, visited Amsterdam to discuss the risks of carrying out clinical trials in developing countries. She joined Wemos and the Centre for Research on Multinational Corporations (SOMO) in considering ways in which the position of vulnerable test subjects can be improved.
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For interviews and/or further information, please contact Leontien Laterveer, Senior Communications Officer at Wemos, on +31 6 10305890 (Wednesdays) or +31 20 4352062 (other working days), e-mail: firstname.lastname@example.org.
The letter sent to European health ministers can be downloaded at www.FairDrugs.org. Further information about unethical testing practices in developing countries is available on www.wemos.nl (see 'Unethical testing dossier').
Wemos is an Amsterdam-based organization contributing to the structural improvement of people's health in developing countries through advocacy: health for all.
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.
'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.'
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.'
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.'
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.'
For more information, contact Leontien Laterveer (Wemos): +31 (0)20 - 435 20 62; +31 (0)6 - 10 30 58 90; email@example.com.
Download the report Ethical concerns in clinical trials in India: an investigation.
Download the Dutch press release.
Download the Spanish press release.