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WHY WE EXIST - THE APOTEX / UofT SAGA
The European Challenge

NEWS RELEASE

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:

Information:
Emily Watkins 416-996-4556
Rose Marie Hewitt 416-996-4556

Doctors for Research Integrity

81 Wychwood Park, Toronto CANADA M5G 2V5

Tel: (416) 996-4556   Fax: (416) 462-0249   E-mail: [email protected]

Website: http://www.doctorsintegrity.com

Co-Chairs: Marc Giacomelli & Dr. Paul Ranalli

 
Copyright 2001 Doctors for Research Integrity.