The NEJM Perspective by 4 top FDA officials raises several questions: what was the FDA’s role in creating the current situation? And is the “reevaluation” mentioned by the FDA officials a good example of “too little, too late”?
Anyone reading the article would be hard-pressed to know that the FDA played a key role in allowing the current situation to develop. Clearly, the FDA could have played a much more pro-active role in the past and have helped prevent the current crisis. Further, the “reevaluation” mentioned by the FDA authors may not address the root cause of the problem, says at least one well-placed expert.
TREAT lead investigator Marc Pfeffer spoke with CardioBrief about the NEJM Perspective. Although Pfeffer expressed broad agreement with the need for a reevaluation, he is also troubled that not enough will be done to address the problem.
Pfeffer pointed out that “the field started with the treatment of severe anemia with patients who needed renal replacmeent therapy, and there is no denying the benefits of ESAs in this setting.” But, says Pfeffer, “the extrapolation to other patients was the fundamental problem and missed the fundamental question: are ESAs better than placebo?”
“Maybe,” wonders Pfeffer, for non dialysis patients with less severe anemia the best hemoglobin target is “not to TREAT.” Pfeffer believes that “the presumption of benefit of raising hemoglobin was so pervasive” that it made placebo-controlled trials impossible.
Pfeffer also questions whether simply lowering the hemoglobin target, or achieving a target more slowly, will make a difference, as the FDA officials suggest in the Perspective. “Everyone thinks if we had gone to a lower hemoglobin in TREAT the result might have been different, but that may be a misconception. To say that there is a safe hemoglobin target has not been proven.”
Links to previous coverage on CardioBrief: