Amgen defends anemia treatments at all costs

by Anne Law, November 19th, 2007, 6:44 am

It seems that the controversy surrounding Amgen’s anemia treatments Epogen and Aranesp will never end, nor will the company’s efforts to keep the drug category at the top of its product list. Not so surprising really, during a time when pharmaceutical patents are fought over like dog bones and the FDA is increasingly strict with its drug approvals and guidelines.

The two products, which accounted for nearly half of Amgen’s revenues in 2006, have seen slowing sales this year due to several medical journal studies connecting the drugs to adverse effects on patients’ hearts. Amgen makes big bucks on the drugs due to their wide use on cancer and kidney dialysis patients. Sales of Aranesp and Epogen declined by 23% and 5% in the third quarter of 2007, and the company has initiated layoffs and other restructuring efforts to offset the losses.

Last week the FDA made Amgen and Johnson & Johnson, whose anemia drug Procrit is in the same class of controversial drugs, add “black box” warnings to the anemia medications, highlighting the risks of taking higher levels of the drugs, which has been connected to increased blood pressure, blood clots, and tumor growth in cancer patients.

In response to the studies, Medicare lowered its level of coverage on the drugs, reducing the dosage levels that would be reimbursed for cancer patients. Kidney dialysis and non-cancer patients weren’t included in the restriction. Amgen is now reportedly spending a heap of cash on its lobbying efforts to get Congress to revoke the Medicare rule. In addition, the company faces the possibility that private insurers will impose similar rules.

Another recent development in the saga, one which actually could be in the company’s favor, is Amgen’s victory in a hearing on patent-infringement charges over Roche’s competing drug Mircera, although the final outcome of that ugly battle has yet to be seen. Mircera is sold in several European countries and has received FDA approval but is not yet sold in the US. If Micera were launched in the US, it would threaten Amgen’s monopoly on selling anemia treatments for dialysis patients.

So, once again we have the story of a rich drug company fighting to protect a cash-cow product whose benefits may –or may not – outweigh its risks. Who are we to believe: Big Brother or Big Business? I personally tend to err on the cautious side — if there are risks serious enough to warrant FDA and Medicare actions, then likely patients and doctors should be careful in using the drugs as well.