There was bad news for cancer patients -- and the biotechnology giant Amgen -- buried in a clinical trial released early yesterday by the New England Journal of Medicine.

The Amgen-funded trial was designed to show that people with failing kidneys given Aranesp for mild anemia had fewer deaths and major cardiovascular events than people given nothing. The company had hopes of expanding use of the drug among chronic kidney disease (CKD) sufferers.

But those hopes were dashed by the results of the 4,038-person trial. Not only was there no cardiovascular benefit for the 2,012 people given a regular shot of the drug, people on Aranesp suffered twice as many strokes.

But the results were even worse for people with CKD who either had a previous history of cancer or were diagnosed with the disease during the trial (188 in the Aranesp arm and 160 in the placebo arm). Those taking Aranesp had a statistically significant increase in cancer mortality.

Overall, 39 died from cancer when taking Aranesp compared to just 25 who died from cancer in the placebo arm. But all of that increase was among people who had cancer or had a cancer history when they entered the trial. Among that group, 14 died while on Aranesp while only one died while on placebo.  

The bottom line is that Aranesp, and perhaps by extension Procrit/Epogen, which are short-acting versions of the same recombinant protein, probably is "Miracle-Gro for Cancer," to use American Cancer Society president Otis Brawley's now famous phrase.

No doubt the company will attempt to explain away this new piece of evidence that threatens to further undermine its already crumbling core franchise, which is among cancer patients. It will argue that the cancer results were merely a subgroup analysis, and that there was not a statistically significant increase in all-cause mortality among cancer patients in the trial (60 died in the Aranesp arm compared to 35 in the placebo arm). But 17 of the 25 additional deaths were from cancer itself, and to repeat myself, that number was statistically significant.

There was no significant difference in the primary outcomes measured: death or cardiovascular events. During the three years of the trial (it ended in 2007), 31.4 percent taking Aranesp either died or had a major event compared to 29.7 percent in the placebo arm. But more than twice as many people suffered strokes -- 101 or 5 percent of all patients taking Aranesp compared to 53 or 2.6 percent of all people taking nothing at all.

Were there any benefits at all from taking Aranesp? The major advertising campaigns for anti-anemia drugs like Aranesp and Procrit stress their ability to reduce fatigue associated with chemotherapy. People with CKD also suffer from anemia-induced fatigue since the kidneys are the primary producers of erythropoietin, the protein that Aranesp and Procrit replace. While 54.7 percent of patients taking Aranesp reported a reduction in fatigue, so did 49.5 percent taking a placebo. Big deal, or to use the more polite wording of the accompanying editorial, "a humble improvement at best."

This trial shows once again that the benefits of taking erythropoietin-stimulating agents (ESAs) like Aranesp, Epogen and Procrit to reduce fatigue (as opposed to salvage therapy to prevent blood transfusion) are far outweighed by the drugs' life-threatening consequences. Even the Amgen-funded investigators didn't mince words in reaching that conclusion. "It is our view that, in many patients with diabetes, chronic kidney disease, and moderate anemia who are not undergoing dialysis, the increased risk of stroke and possibly death among patients with a history of a malignant condition will outweigh any potential benefit of an ESA," the investigators in the Trial to Reduce Cardiovascular Events with Aranesp Therapy (TREAT) wrote.

"The results of the TREAT will influence practice guidelines and inform physicians, patients, and policymakers," echoed Philip A. Marsden of the University of Toronto in an accompanying editorial. "In many of these stakeholders, the risk of stroke will outweigh the potential benefits of darbepoetin alfa (Aranesp)."

But Marsden, a nephrologist who treats kidney disease patients, skated over the cancer findings with barely a nod. Oncologists -- and the Food and Drug Administration, Medicare and Medicaid -- should take a hard look at these findings. The evidence is mounting that these drugs, when used routinely to reduce fatigue, present a clear and present danger to cancer patients.