Three anemia drugs, among the “best selling prescription drugs in the United States,”[1][1] Epogen, Procrit and Aranesp, produced more than $8 billion in sales for big pharmaceutical manufacturers, Johnson & Johnson and Amgen.[2][2] According to a recent Washington Post article, it is troubling then that for more than 20 years, the risks of taking those drugs, including “cancer and strokes,” were seriously understated while some wholly unrealistic benefits—“life satisfaction and happiness”[3][3]—were highly touted while patients died. The results of an 84-page study by Medicare researchers noted that “among kidney patients,… the largest market for the drugs, there was no solid evidence they made people feel better, improved their survival or had any ‘clinical benefit’ besides elevating a statistic for red blood cell count.”[4][4]
But patients must trust their doctors, and the drug companies provided incentives to doctors, hospitals and clinics and, in so doing, influenced decisions doctors made to administer these medications to their patients. The drug makers offered discounts to practices that dispensed the drug(s) in big volumes. In addition, “the company’s lobbying pressure” influenced Congress and Medicare to sanction “a system where doctors would be reimbursed more for the drug than they were paying for it.”[5][5] Reimbursements from Medicare patients accounted for 30% of the companies’ tremendous increase in profit margins. Amgen became a Fortune 500 company. By 2007, over 80 percent of 175,000 Medicare patients on dialysis were receiving an anemia drug (Epogen) “at levels beyond what the FDA now considers safe.” When it became apparent that serious dangers and increased mortality were associated with this drug, “the company continued to promote higher doses,” stated Daniel Coyne, professor of medicine at Washington University, a former paid speaker for Amgen.
The roller-coaster “rise and fall” in popularity of anemia drugs is a prime example of how economic incentives in the present “US health care system can make it [the system] not only inefficient but potentially deadly.”[6][6] While some at the FDA raised concerns about these drugs’ safety and there were studies, all too frequently results were only partially reported. One study was concluded 15 years after it was begun, long after the damage was done. The fact that “Neither Amgen nor the FDA would release a copy of the study report”[7][7] evokes questions about FDA’s and the company’s roles in the anemia drug scandal. Years later, relatives still want to know what killed their loved ones, the disease or the drugs?
[1][1] “Anemia drugs made billions, but at what cost?”, Whoriskey, Peter, July 19, 2012, The Washington Post, Washington, D.C., http://www.washingtonpost.com/business/economy/anemia-drug-made-billions-but-at-what-cost/2012/07/19/gJQAX5yqwW_print.html
[2][2] Op. Cit.
[3][3] Ibid.
[4][4] Ibid.
[5][5] Ibid.
[6][6] Ibid.
[7][7] Ibid.
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