The New England Journal of Medicine published an interesting series of editorials this week about ESA’s. (erythropoesis stimulating agents, click here and here). For the non medically inclined, these are injectable agents which stimulate the bone marrow to produce red blood cells. I want to point out some fascinating things I learned from these articles.
One is that it is NOT indicated for anemia from cancer. It is only recommended for anemia secondary to chemotherapy, or at least it was only evaluated on that basis, an attempt to reduce the number of transfusions required.
Secondly, it is NOT approved by the FDA for alleviating fatigue or weakness or to improve a patient’s quality of life. In fact, the FDA has stated that there is “no evidence that [the agents] improve quality of life or cancer outcomes”.
I didn’t realize that, and from the commercials released by Amgen, you’d suspect otherwise. You remember those, right? An older woman is power walking and she describes how her fatigue was due to anemia and the Procrit had given her back her energy. Well, since there was no evidence to back up that little bit if play acting, why was it allowed to air?
Well, the FDA’s own Oncologic Drigs Advisory Committee recently criticized these very ads and director Richard Padzur made this helpful quote, saying the FDA should give “the American public…the reason why these ads were allowed to go on”.
I don’t think we need to look too far for the reason. My guess is, it’s green, made of paper, and can buy a lot of nice things.
Finally, I did not know that it INCREASED your risk of dying of your cancer. And I’m not just talking about hematologic cancers. Apparently HEAD AND NECK cancers! And METASTATIC BREAST CANCER! How in the world does this happen? No one has a clue right now, because there just isn’t any good test to detect if there are receptors on these tumors for the drug, or if its due to more angiogenesis and, thus, more tumor proliferation.
Talk about your poorly publicized facts.
I have given ESA’s to many anemic patients suffering from end stage renal disease and if they have chronic disease anemia without underlying bleeding, or if they required a lot of transfusions, but were refusing surgery or colonoscopy. I never tried to get the hematocrit about 30% and I don’t think these papers apply as much to my practice as an oncologist’s. But I still think its more evidence of chicanery between the FDA and Big Pharma, and 180 degrees removed from the best interests of patients.
Ok, off for a few days with the family. See you next week.
And STAY ANGRY!!!!!!!