Attention: News and Medical Editors
Sunday April 27, 2003
For Immediate Release
Documentary Fails to Reflect Lifesaving Role of Drug for Patients
Afflicted with Thalassemia, a Rare Blood Disease
LONDON, UK – True Vision’s documentary, Dying for Drugs, which aired on Channel 4 at 8:30 PM, tonight, misrepresented many elements of the development of Ferriprox® (deferiprone), a drug developed by Apotex Inc. for the treatment of a life-threatening condition-chronic iron overload, a condition prevalent in thalassemia patients.
Prior to deferiprone, there was only one drug for the treatment of patients with iron overload, and it required daily injections of 8-12 hours, for the rest of the patient’s life. In search for an alternative medicine, specialists in the UK and around the world, devoted up to 15 years of their lives to evaluate the safety and efficacy of deferiprone in thousands of patients. As a result of their positive findings, Ferriprox® has been approved as a life-saving alternative for patients in 25 countries, including those of the European Union.
True Vision’s documentary included an interview with Dr. Olivieri, a physician who claimed Apotex terminated her studies with Ferriprox® because she “discovered” negative effects of the drug, and the company wanted to prevent her from reporting her findings. True Vision neglected to reveal the efforts taken by Apotex to assess Dr. Olivieri’s alleged claims. In fact, Apotex did not suppress her claims, but distributed her findings to all of the specialists evaluating Ferriprox in Canada, the United States and Europe. Unanimously, they disagreed with her interpretation of the data. Apotex also convened an international expert panel to review her data and they also concluded that there was no basis for her claims. None of Dr. Olivieri’s supporters who were interviewed in the program has ever studied the drug, nor has any ever met with Apotex to learn if her claims regarding the drug or of academic freedom were true.
Three months after her contract had been terminated because of extensive problems, including protocol violations, which she now denies, Dr. Olivieri chose to publish her views. The company disagreed with her presentation of unfounded conclusions, but stated that if Dr. Olivieri were to publish her views, then those of her peers should be presented as well. Instead, she presented her position without acknowledging the dissenting views of her peers, and she continues to misrepresent the reasons for Apotex terminating her contract.
“We believe, particularly in this case, that there is a responsibility that comes with the right of academic freedom – that is the duty of full disclosure, a critical element of scientific honesty”, stated Dr. Fernando Tricta, Medical Director of Apotex. “The scientific literature has now demonstrated that her claims were scientifically unsound. Unfortunately, as scientists around the world conducted their research that disproved her allegations, many patients were denied access to the medication, with the subsequent consequences of morbidity and mortality in those who had no alternative treatment”, concluded Tricta.
The European Commission granted the first regulatory approval for the marketing of Ferriprox in August 1999. “The European Commission, through its drug regulatory arm the EMEA, gave a thorough hearing to Dr. Olivieri’s allegations, and after considering them, carried on with its decision to grant Marketing Authorization under Exceptional Circumstances, a condition which has now been lifted because of the positive results with the drug”, stated Dr. Michael Spino, Senior VP, Scientific Affairs, Apotex Inc. “After six years, Dr. Olivieri remains the only investigator who has treated patients with deferiprone and reported a negative benefit to risk ratio”, concluded Spino.
“It is unfortunate that True Vision made a decision to rely on Dr. Olivieri’s point of view for a documentary aired in London. They would have learned a lot if they had taken the time to talk to the hundreds of patients around the world whose lives have been saved, or to the dozens of other researchers who have studied the drug, or to the doctors who are prescribing the medication, or to the Thalassemia patient groups in this country who have followed this issue.” stated Michael Michaels, President of the United Kingdom Thalassemia Society.
Interested parties may obtain a list of clinical studies in the Peer-Reviewed literature regarding the benefits and risks of deferiprone published in the last year, by writing to the following contact.
- 30 -
For additional information, please contact:
Elie Betito
Director
Public and Government Affairs
Tel: (416) 749-9300
Cell: (416) 985-1067
ebetito@apotex.com
