For release on Friday, February 11, 2000
EUROPEAN COURT TO HEAR
OLIVIERI APPLICATION ON FEBRUARY 15, 2000
RE: INJUNCTION FOR DRUG DEFERIPRONE
(Toronto, CANADA. February 10, 2000.)
The European Court of Justice will hold a preliminary hearing
of an application for an injunction brought by Canada's Dr. Nancy
Olivieri to halt the marketing of deferiprone in the European
Union until the drug has been clinically tested. The hearing will
take place in Luxembourg on Tuesday, February 15, 2000.
"This is only the first stage in what may be protracted
proceedings, and procedural reasons may be invoked to avoid imposing
an injunction at this time" said Dr. Paul Ranalli, Co-Chair of
Doctors for Research Integrity, (DRI) a group of over 300 physicians
and individuals supporting Dr. Olivieri's challenge.
"The case presents novel challenges for the Court
since it is the first time ever that the Court has been faced
with a claim from an individual on the authorization by the European
Commission of a new drug", added Ranalli, a Neurologist at the
University of Toronto. "Dr. Olivieri's findings are compelling.
We therefore urge that caution be exercised in approving this
drug to ensure that patient safety is protected".
Grounds for the application include: 1) controlled
Toronto studies (showing a risk of severe damage to health in
about 50% of patients treated) were not reviewed fully by the
European Commission; and 2) a number of errors of medical fact
were submitted to and accepted by the European Commission and
its Agencies during the drug approval process.
Dr. Olivieri's life-long hope of finding a new drug
for thalassemia patients was shattered in 1996 when, during the
only controlled trials of the drug to examine liver toxicity,
deferiprone showed disturbing results of possible damage to the
liver. "The drug company sponsoring deferiprone is taking the
drug to market without any more controlled trials for liver toxicity"
said Ranalli "and we are concerned that patient safety may be
compromised. We are asking that new prospective controlled clinical
trials be ordered before the drug is licensed for sale."
In 1996, the drug company prematurely halted Dr.
Olivieri's clinical trials. "No other clinical trials have been
held. Patient safety may be at risk because Dr. Olivieri was never
allowed to present her findings directly to the European Commission
and its Agencies, in person" concluded Ranalli.
DRI is encouraging individuals and medical practitioners
to contact them in Canada at 416-996-4556 or at the DRI website:
Emily Watkins 416-996-4556
Rose Marie Hewitt 416-996-4556
Doctors for Research Integrity
81 Wychwood Park, Toronto CANADA
Tel: (416) 996-4556 Fax:
(416) 462-0249 E-mail: [email protected]
Co-Chairs: Marc Giacomelli
& Dr. Paul Ranalli