Amgen Hammered Anew

For chemotherapy patients, "there is no evidence that ESAs improve the quality of life or cancer outcomes," the report says. "There are insufficient data from adequate and well-controlled studies" to determine if recommended doses improve survival or affect tumors.

Since an advisory panel meeting in May 2004, neither J&J nor Amgen has provided any relevant data to assess these risks, the staff says.

According to the FDA, clinical trials show about half the anemic patients who received chemotherapy alone required transfusions. Around 20% to 25% of patients receiving chemotherapy plus ESAs needed transfusions. "Thus, many more patients are exposed to the risks of ESAs than receive benefits in terms of avoidance of the risks of transfusions," the staff report says.

A review of clinical trials and other data shows that risks linked to blood transfusions have declined ever since the first ESA was approved in 1993. But research also shows a higher risk of death and "possible tumor promotion" from ESAs, the FDA staff says.

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