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.
"Amgen and Aranesp: One more example of how drug companies make huge profits by misleading consumers" - was the headline blogger Alison Bass used. She continued:
These results, which came from the kind of randomized study considered the gold standard of research and which counter years of aggressive marketing by Amgen, were released hours after the attorneys general from Massachusetts and 14 other states sued Amgen in federal court alleging that the company offered kickbacks to doctors to boost sales of Aranesp.