Artificial blood products increased the risk of death by 30 percent and almost tripled the risk of heart attacks in 16 clinical trials, according toa study in the Journal of the American Medical Association. The researchers write that the FDA should have stopped the studies eight years ago, but meanwhile five trials are still under way and another is about to begin.
Eight years ago, the FDA received data on individual studies showing increased risks that should have triggered suspension of testing until a large-scale analysis could be conducted, according to the researchers, who say the FDA should end the trials and Congress should review rules forcing the agency to keep info on new products confidential for competitive reasons.
"One straightforward solution to these problems would be for Congress to reverse the FDA's policy of treating as confidential all corporate materials submitted during the product development process, including the investigational drug application,'' the researchers wrote. The blood products studied were made by Baxter International, Biopure, Hemosol BioPharma, Northfield Laboratories and Sangart.
"If you have secret science, things like this can happen,'' Charles Natanson, a septic shock researcher at the National Institutes of Health, tells Bloomberg News. "Once you've randomized patients, your results can't be a trade secret. It's a measure of protection to the American public.''
But Jay Epstein, director of the FDA's office of blood research and review, tells Bloomberg that analyzing several studies together as one has its limitations. And he adds that the agency also has unpublished info not available to the study's authors that shows potential benefits of artificial blood. It's not clear whether that info will be discussed at an FDA workshop being held tomorrow to review the products.