Amgen's big-selling anemia drugs were first brought in for questioning a few years ago. Studies and side-effect reports cast doubt on their safety. The FDA started a review. Then, in 2007, FDA slapped a "black box" warning on Epogen and Aranesp, citing risks of heart problems at higher doses.
And the interrogation continues. The Washington Post takes a close look at the drugs, sifting through safety data and government documents to present a play-by-play of the saga. Like Department of Justice investigators who've been probing the company's marketing practices for years, the article rounds up regulatory actions, dosage debates and reimbursement moves.
But it also looks past that back-and-forth among regulators, Amgen ($AMGN), and Johnson & Johnson ($JNJ), which markets an Amgen-made anemia product, Procrit. For instance: Amgen's intensive marketing persuaded doctors to boost dosage levels, and when the risks of those higher doses arose, lobbying in Washington helped fend off dosage limits proposed by Medicare, the Post reports.
The Justice Department's ongoing probe focuses on that intensive marketing. Whistleblowers have claimed that Amgen promoted the drugs off-label and offered doctors kickbacks to boost Aranesp sales. Late last year, the company set aside $780 million to settle federal investigations and whistleblower claims related to anemia-drug marketing.
The reimbursement questions are another thing altogether. As the Post reports, it's not just the political pressure applied to keep Medicare from cracking down on anemia-drug reimbursements. It's also the very structure of those reimbursements, which are set higher than doctors' costs for the drugs, allowing providers to profit off the spread.
These drugs are far from the only ones reimbursed in this way. Amgen is also far from the only drugmaker accused of marketing violations. It should be noted that Amgen has denied misleading anyone about its drugs' safety or effectiveness, and says that its salespeople are trained to market drugs responsibly.
But as the Post points out, the anemia-drug example underscores flaws in the U.S. healthcare system, and weaknesses in the regulatory and reimbursement framework. And it shows how drugmakers have every incentive to push the envelope. Amgen's proposed $780 million settlement is just a small fraction of its billions in anemia-drug profits.
- read the Post analysis
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