The Business Of Law

New research published in The New England Journal of Medicine says that patients suffering from kidney disease who took the drug Aranesp may be at greater risk of having a stroke.  An earlier, separate study has found that patients who took the drugs were twice as likely to suffer from blood clots in the lungs and legs as other patients.

The new research, conducted by Dr. Mac Pfeffer at Brigham and Women’s Hospital in Boston, found that twice as many patients who took Aranesp, manufactured by pharmaceutical  giant Amgen, suffered a stroke versus the placebo. The researchers say they don’t yet know why the stroke risk was so much higher.

Aranesp is one of a class of drugs commonly referred to as ESAs, or erythropoiesis-stimulating agents, and have been used by doctors treating anemia and low blood counts in cancer patients.

According to Mike Huckman, the pharma beat reporter over at CNBC:

“The study, which Amgen paid for, was done on more than 4,000 people who have type 2 diabetes, chronic kidney disease and anemia, but who were not on dialysis.

Amgen says it has already shared the data with the Food and Drug Administration and that it expects the results to eventually be turned into a warning on the drug’s label. Aranesp is designed to boost red blood cells, give people more energy and cut the need for transfusions. Other recent studies showed the drug may also cause tumor growth, resulting in new FDA warnings. “

But the study raises some interesting conflict of interest questions.  As CNBC notes, it was released on the same day that NY AG Andrew Cuomo  announced a lawsuit against Amgen related to alleged kickbacks to doctors for prescribing Aranesp.  Also interesting is that Dr. Pfeffer has received consulting fees from Amgen, and was given a grant from the pharma giant to conduct his study.

It will be interesting to see how this study plays into legal action against the drug maker. We’ll be ready, let us know when you are. Feel free to drop me a note.