In what was described as an “ingenious and well-coordinated series of marketing schemes that endangered patients while enriching doctors,” Amgen, Inc. paid a hefty price for promoting off-label uses of Aranesp, its multi-billion dollar anemia drug.
Amgen perceived an off-label marketing opportunity for Aranesp in 2003, when arch competitor Johnson & Johnson halted studies of its drug, Procrit, used to treat anemia in patients with cancer and other chronic diseases. Aranesp’s lone FDA-approved oncology use was treating chemotherapy-induced anemia. However, the market for treatment of anemia in cancer patients who are not receiving chemotherapy was three times larger.
In an effort to tap this larger market, and significantly grow Amgen’s shares, the company developed a scheme to fill the void left by J&J’s removal of Procrit, and began marketing Aranesp to treat the “Anemia of Cancer (AOC)” — which was a non-approved, off-label use of the drug. To execute its scheme, Amgen sponsored a small study purporting to show that Aranesp was effective for this condition, although the study’s parameters were clinically inadequate to substantiate the safety or efficacy of the drug for this use. Nevertheless, Amgen used the study to obtain coverage of Aranesp for AOC in an influential medical publication that lead to Medicare coverage for what, in fact, was an untested use.
“What Amgen didn’t know after it launched the Aranesp schemes, was that our client, a long-time marketing rep, recognized the danger to patients and, on her own, reported her concerns to the Government. Later, Department of Health and Human Services Office of Inspector General Special Agents asked her to work undercover for them,” said attorney Brian Kenney, of Kenney & McCafferty, P.C.
After eight years of undercover work, the whistleblower garnered a wealth of the evidence against Amgen, and the information she provided in her case became a key to the federal Government’s $762 million global settlement. The settlement is comprised of a $612 million civil settlement, a $14 million criminal forfeiture payment and a $136 million criminal fine.
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