Yesterday, the Journal of the American Medical Association released a report that stated that an analysis involving the use of hemoglobin-based blood substitutes (HBBS) indicates that their use is associated with a 30% increased risk of death and an almost three times increased risk of heart attack. Clinical trials as early as 1996 pointed to questions about the safety of such HBBS and have yet to prove their benefits. Prompt analyses by the FDA of these trials “most likely would have demonstrated significant risks by 2000,” the report states.
The regulatory process that permitted repeated trials of the HBBS in the past eight years despite the increased risks of death and heart attack needs to be addressed and overhauled. While the sponsors of the clinical trials are required by law to report their results to the FDA in a timely fashion after the studies are completed even if the research isn’t published, these results are not required to be made public by the FDA unless the product is approved or an advisory committee is convened to discuss the product.
These particular trial results weren’t made public until well after the trials had stopped enrollment, and as such, patients who chose to enroll in these trials were doing so without fully informed consent. This is not acceptable. All trials results need to be reported promptly to not only the FDA, but must be made available to the scientific and medical communities as well as those who are making the decisions to enter further clinical trials. Anything less will cause bad blood indeed.
