[e-drug] EU drugs tested in unethical clinical trials in developing countries

["Leontien Laterveer" <leontien.laterveer@wemos.nl>]

E-DRUG: EU drugs tested in unethical clinical trials in developing countries
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[Full SOMO report available at: www.somo.nl/html/paginas/pdf/Ethics_for_Drug_Testing_feb08_EN.pdf 
The WEMOS report is available at: www.wemos.nl/Documents/a_bitter_pill.pdf
WB]

Press release 19 February
European citizens swallow bitter pill 
New drugs approved for EU market tested in unethical trials

Amsterdam, 19 February 2008 - Today, the Centre for Research on
Multinational Corporations (SOMO) and the Wemos Foundation present new
evidence that 'unfair' drugs, medicines which have been unethically tested
in low-income and middle-income countries, are being given approval for use
on the European market. They call upon the European Parliament to take
urgent action.

In its report Ethics for drug testing in low and middle income countries:
Considerations for European market authorisation SOMO analyses the
justification for the use of placebos and the participation of vulnerable
patient groups in phase III clinical trials. The report shows that European
authorities grant EU marketing authorization based on clinical trials which
are unethical. It also demonstrates that these authorities actually
encourage the offshoring of unethical trials to countries outside Western
Europe by requiring trials that are no longer accepted by the ethical review
committees in Western Europe. As a result, controversial trials end up being
conducted in low-income and middle-income countries where local regulatory
authorities and ethical review committees are ill-equipped to cope with the
enormous upsurge in the number of clinical trials.

"The consequences of this practice are serious", warns SOMO researcher Irene
Schipper. "For example, in one placebo-controlled trial to test Seroquel XR,
an antipsychotic drug for the treatment of patients with schizophrenia, a
25-year old man committed suicide after 173 days of placebo treatment and
8.3 percent of the patients receiving a placebo required hospitalization due
to worsening of their disease. This trial was conducted in Bulgaria, India,
Poland, Russia and Ukraine and was only aimed at investigating the
differences between formulations of the same antipsychotic. According to the
Declaration of Helsinki, this type of trial can never justify the use of a
placebo because it involves withholding treatment from seriously ill
patients. Nevertheless, the Dutch Medicines Evaluation Board (CBG) approved
Seroquel XR for the EU market." The public assessment report for Seroquel is
still not available, despite the fact that the CBG is legally required by EU
Directives to publish it without delay. This lack of transparency is not
limited to the Seroquel case. In general, SOMO has experienced great
difficulty in obtaining information about where clinical trials were
conducted and which ethical considerations were made.

The new Wemos-report A Bitter Pill is the first to provide an overview of
the risks involved when clinical drug trials are carried out on the
inhabitants of developing countries. Wemos puts forward concrete proposals
for improving the protection of these vulnerable test subjects. It places
particular emphasis on stricter checks by the bodies charged with the
approval of new medicines and their admission to the European market, in
other words the European Medicines Agency EMEA and the national registration
authorities of each EU member state. Equally important is the compulsory
registration by pharmaceutical companies of all trials in a publicly
accessible register. A Bitter Pill includes a preface by Dr Heleen Dupuis,
Professor of Medical Ethics and a Member of the Dutch Upper Chamber of the
States General. 

Tomorrow in Strasbourg, a coalition of five organizations including Wemos,
SOMO, Farmacie Mondiaal, Health Action International (HAI) Europe and the
European Medical Students' Association (EMSA), will present the reports to
Dutch MEPs Dorette Corbey (Labour) and Maria Martens (Christian Democrats).
The coalition will call on politicians to put a stop to 'unfair' drugs. 

For more information, please contact:
-	Irene Schipper,  SOMO senior researcher, on +31 20 6391291, e-mail:
i.schipper@somo.nl; or 
-	Leontien Laterveer, Wemos Communications Officer on Medicines, on
+31 20 4352050; e-mail: leontien.laterveer@wemos.nl

Both the Wemos and SOMO reports are available from www.wemos.nl and
www.somo.nl. 


Wemos, SOMO, Farmacie Mondiaal, Health Action International Europe and the
European Medical Students' Association are collaborating on the issue of
clinical drug trials in developing countries. 

About Wemos: 
The Wemos Foundation is an Amsterdam-based organization contributing to the
structural improvement of people's health in developing countries through
advocacy. For more information, please go to www.wemos.nl. 

About SOMO:
SOMO is a Dutch non-profit research and advisory agency that has been
investigating the consequences of the corporate policy of multinational
enterprises and the consequences of industrial globalisation since its
establishment in 1973. More information at www.somo.nl.
 
About Farmacie Mondiaal:
The Dutch organization Farmacie Mondiaal (www.farmaciemondiaal.nl) is
involved in structural support of pharmacy and pharmaceutical services in
developing countries. Farmacie Mondiaal is supporting the use of affordable
and ethically developed drugs that are rationally used. For more
information, please person Tjalling van der Schors; mobile: +31 6 -
26946095; e-mail: vdschors@quicknet.nl.

About HAI Europe:
Health Action International Europe is a non-profit, growing, European
network of consumers, public interest NGOs, health care providers,
academics, media and individuals with 25 years experience in representing
the voice of civil society, the poor and the marginalised in medicines
policy debates. For more information, visit www.haiweb.org.

About EMSA:
The European Medical Students' Association (EMSA) is a non-political
organization made by medical students for medical students. EMSA's main
objective is to create a network of medical students all over Europe and to
provide a meeting place where these students can come together to share
experiences, ensure the quality of medicine in Europe and to discuss the
social, cultural, academic, economic and ethical aspects of medicine. More
information at www.emsa-europe.org. 

Leontien Laterveer
WEMOS
Netherlands
E-mail: leontien.laterveer@wemos.nl