I don't really have much to add to this fine reporting by Alex Berenson and Andrew Pollack in the NYT, except that I'm free to characterize the situation, while they must exercise reportorial discretion.
You may have seen those ads on TV for agents that stimulate erythropoiesis, that is the production of red blood cells. The ads were targeted at patients undergoing cancer chemotherapy, of which anemia is a common side effect. Lately you may have heard that there has been a controversy over Medicare reimbursing kidney dialysis centers for using high doses of these drugs (brand names Aranesp, Epogen, and Procrit), because it turns out that using too much of them can have the unfortunate side effect of killing the patients. The FDA has issued a black box warning, just two months ago:
- Avoid serious cardiovascular and arterial and venous thromboembolic events by using the lowest dose of Aranesp, Epogen, or Procrit that will gradually raise the hemoglobin concentration to the lowest level sufficient to avoid the need for blood transfusion.
- Aranesp, Epogen, and Procrit and other erythropoiesis-stimulating agents increased the risk for death and for serious cardiovascular events when dosed to achieve a target a hemoglobin of greater than 12 g/dL.
- Use of erythropoiesis-stimulating agents to achieve a target hemoglobin of 12 g/dL or greater in cancer patients shortened the time to tumor progression in patients with advanced head and neck cancer receiving radiation therapy; shortened overall survival and increased deaths attributed to disease progression in patients with metastatic breast cancer receiving chemotherapy; and increased the risk of death in patients with active malignant disease not under treatment with chemotherapy or radiation therapy. Erythropoiesis-stimulating agents are not indicated for this patient population.
- Patients treated before surgery with epoetin alfa to reduce allogenic red blood cell transfusions had a higher incidence of deep vein thrombosis. Aranesp is not approved for this indication.
So what to Berenson and Pollack find? Here's the bottom line. They can't say it, but I will. The drug companies have been bribing doctors -- to the tune of hundreds of millions of dollars a year -- to give excessive doses of these agents and, uhh, kill people. That's it. Murder for gain. Tell me why it isn't.