Summary
Over the last year, it has become clear that the over-use of anemia drugs for cancer and renal failure has become a problem. The reason can be sumed up in one word, which is profit.
Analysis
Prior to the introduction of erythropoietic stimulating agents, the only thing a physician could do for a patient with anemia was to transfuse a unit of blood. Particularly in the field of dialysis, especially prior to the 80's, blood borne pathogens of all types, such as HIV, Hepatitis B, C and D, were spread due to the fact that regulated testing, at that time, was not as good as it should be. So, the advent of epoietin alpha was a God send to cancer and renal patients. However, as time progressed, providers began to see the profit potential of the drug and that's when the abuse began.
I have followed Amgen and Johnson & Johnson since the introduction of epoietin alpha, back in the late 80's. In the beginning, we were very careful about how much EPO we administered and how high the patient's hematocrit/hemoglobin rose, always being careful to keep the hemoglobin level around 11. Sadly, as providers realized the profit potential of the drug, "experts" began to suggests that patient's hemoglobins be pushed to higher, nearly normal levels. This could be done, but not without side effects, such as strokes and cardiac arrest. And, for patients on dialysis, it could also cause clotting of the hemodialysis access, which is their life line.
As the negative side effects have become documented, the FDA and members of Congress have begun to evaluate and suggests lower hemoglobins. As a result, both Amgen and Johnson & Johnson have seen less of their product used. As well, profits for epoietin alpha have dropped dramatically.
Amgen and J&J are about to receive another wake-up call from Affymax's new ESA drug, Hematide (r). Hematide, unlike DynEpo and CERA, has the capability to get around Amgen's ESA patent. Hematide has passed phase II clinical trials of it's drug:
http://www.bio-medicine.org/medicine-technology/Affymax-Reports-Phase-2-Clinical-Dose-Ranging-Results-of-0AOnce-Per-Month-Hematide-for-the-Treatment-of-Anemia-214-2/. In light of this fact, for the first time, I see competition for Amgen & J&J's EPO on the horizon.
