FDA Eyes Safety of Popular Anemia Drugs
Chemo-Related Drugs May Spur Early Death in Cancer Patients and Others
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American Volunteers Needed
Still, regulators and experts remain concerned that most if not all of the large EPO studies were performed in Europe and not the U.S. Officials expressed worry that American patients and their doctors may continue to shy away from signing up for trials where they could be randomized to take EPO or a placebo.
"The real question is, will they be willing to be randomly assigned," says Musa Meyer, a consumer advocate and member of the FDA's advisory panel for oncologic drugs. "I think there are physicians for whom it will be an issue."
Company officials said that several trials testing EPO drugs in patients with lung cancer, breast cancer, lymphoma, and head and neck cancers are continuing to recruit hundreds of patients. But those studies are all continuing in Europe.
"We will have those data very shortly," says Martine George, vice president for hematology and oncology research for Procrit maker Johnson and Johnson. Trials in the U.S. have largely ground to a halt because researchers have had trouble getting patients to sign up.
"We believe the findings should absolutely be applicable to United States practice," Parkinson says of the European research.