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Alert Number 3

Two Popular Anemia Drugs Under FDA Scrutiny

Date: March 20, 2004

Reuters reports the FDA is considering whether two anemia-fighting drugs often used in CLL may have some unintended consequences. Aranesp (Amgen) and Procrit (Johnson & Johnson) are almost household words in CLL circles, justly famous for improving hemoglobin and red blood cell counts. In patients suffering from debilitating fatigue due to low red blood cell counts, these drugs can seem almost miraculous in the effect they have on quality of life. But now there is concern there may be some unintended and potentially serious consequences of using these drugs in some settings, consequences such as rapid stimulation of tumor growth, early relapse and even shorter survival of patients given larger than normal doses of these drugs.

The FDA still believes the drugs are safe, and a lot more palatable alternative to dependency on blood transfusions. Unfortunately, CLL patients receiving chemotherapy are often prone to debilitating anemia because of bone marrow suppression as a consequence of the chemotherapy drugs.

This question was raised by large scale and well conducted European studies of similar EPO products. In these clinical trials, patients received higher than normal doses of EPO drugs, to see if they might synergize with chemo or radiation by boosting cell kill. The idea was to get patients closer to "normal" levels of hemoglobin, not just enough to get over the bare-bone anemia level. One such study was combination of EPO drugs with radiation treatment for head and neck cancer. To the dismay of the researchers, the group that got the additional EPO drugs relapsed sooner and had significantly shorter survival, compared to the group that got just the standard radiation treatment. Not good news, and most unexpected.

Another trial (this time breast cancer patients) undergoing chemotherapy was halted early because higher death rates among those given Johnson & Johnson's Eprex, (J&J's trade name in Europe). Some deaths in the experimental group resulted from progression of cancer, and others from blood clots. Blood clot formation is a known risk of anemia drugs (you can be forgiven for not knowing that, if you based your information solely on the heart warming and dramatic ads on TV), but the more rapid tumor progression is a surprise, and cause for concern.

I have felt for sometime that growth factors (and EPO drugs are growth factors, as are also G-CSF (Neupogen) and GM-CSF (Leukine)) have a built in risk factor of fuelling cancer proliferation. Not all the pathways by which these extremely important drugs work are well understood. In the opinion of this layperson reporter, not enough attention is paid to the clear pro-angiogenesis role of these growth factor drugs. Combination therapies using these drugs may get higher response rates, but unless there is serious attention paid to controlling the angiogenesis aspects after end of therapy, the hard won remissions may be sort lived. Sort of like winning the battle but losing the war. Some of this logic is spelled out in more detail in the "Round Headed Kid" articles.

For more information on this please read our article The Dark Side of Epoetin.

Be well,


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