EPO: Blood Diamond Under Scrutiny At FDA and CMS

  • by: |
  • 05/15/2007
A lot of coverage about the risks of using EPO -- the anti-anemia drug produced by Amgen and J and J mainly in the news. Much of the coverage is the typical "the drug companies pushed over and off-label use so people died" which is probably 5 percent accurate in that you can always find the cowboys and bad apples in any endeavor.

For the most part the use of EPO in treating patients with chronic kidney failure and patients at risk for anemia has been safe, sane and subject to study via observational and randomized clinical trials. Indeed, reading accounts of the cautions placed on the use of EPO you would think the companies were bribing docs to pump as much of the stuff into people as they could. Quite the contrary. Medical literature abounds with studies about what is the right dose to increase survival while not risk the lives of very sick patients. This research in turn is then evaluated, transparently and independently, into guidelines that are continuously adjusted. In some cases, physicians believed that super-corrective hemo-levels were preferable or tried, with very sick and anemic patients, to give them additional strength even through they were not receiving chemotherapy. It may be not be a perfect approach but patient concerns are and were front and center in most cases.

The most recent clinical trials are a culmination of this ongoing effort. That it might lead to a decline in sales should not be a consideration. Finding the right dose for the right patient should be.

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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