The revolutionary findings were published in the New England Journal of Medicine in April of 1995. But, as with any new findings in drug research, a lot more work was needed to prove that deferiprone was safe and effective with long-term use. The researchers started planning a much larger study with Apotex, in conjunction with the Medical Research Council of Canada and the U.S. National Institutes of Health. It was at this stage Dr. Olivieri signed the ill-fated agreement with the Apotex firm. In the fall of 1995, liver biopsies in some of the Toronto patients showed dangerous levels of iron overload throwing the researchers into a panic.
Toxic levels can compromise liver function and lead to scarring and life-threatening cirrhosis.
Dr. Olivieri immediately stopped giving the drug to those patients most at risk but, at the time, was convinced the study should continue in those in whom the drug appeared useful. The researchers thought the drug treatment could be appropriate for some of the patients. The only way to find out for sure was to keep the study on track and carefully monitor the patients. When Dr. Olivieri approached Apotex with her negative findings and a request to change the patient consent form to include the contraindications, the company disagreed that the patients were at risk. Apotex opposed changing the consent form.